WO2023042971A1 - Method for predicting and managing menstrual disorder, and digital therapeutic agent - Google Patents

Abstract

Disclosed are a method for predicting and managing a menstrual disorder, and a digital therapeutic agent. The disclosed method comprises the steps of: receiving state information about a patient's physical state and psychological state related to a menstrual disorder of the patient, which is measured and collected by a digital smart device; collecting and analyzing, by a menstrual disorder prediction and assessment unit, the received state information, and predicting or assessing, according to a result of the analysis, whether the patient has the menstrual disorder and the severity of the menstrual disorder; and when the patient is predicted or assessed to have the menstrual disorder, generating, by a personalized therapy generation unit, patient-specific personalized therapy for the menstrual disorder according to the severity of the menstrual disorder, and providing the personalized therapy to the digital smart device, so as to manage the menstrual disorder. According to the disclosed method, the menstrual disorder may be managed by analyzing symptoms of the menstrual disorder, predicting and assessing the menstrual disorder, and providing personalized therapy by using a smartphone application and a smart device.

Description

Methods and digital therapies for predicting and managing menstrual disorders

The present invention relates to digital treatment technology, and in particular, menstrual disorders that predict and evaluate menstrual disorders by themselves using clinical information of a target patient acquired through a digital device, and manage menstrual disorders of the target patient according to the results. It relates to methods and digital therapeutics for predicting and managing

Premenstrual syndrome generally refers to the appearance of physical, mental and behavioral symptoms that interfere with daily activities related to menstruation, and is caused by various factors such as hormonal changes due to the menstrual cycle and is accompanied by various emotional and physical symptoms ( see reference [1]). A severe form of premenstrual syndrome is called premenstrual dysphoric disorder, which is a disorder that causes severe impairment in daily life. Premenstrual syndrome has a characteristic that it occurs periodically and symptoms mainly occur in the luteal phase after ovulation, and these symptoms may be severe enough to interfere with daily life.

Psychological symptoms of premenstrual syndrome include tension, anxiety, sensitivity, etc., nervousness, depression, and sometimes hostility toward people around you for no reason. In general, they avoid social life and want to be alone, and sometimes they do not do their usual work properly. In severe cases, they lose self-control and shout loudly or fight with others. In addition, physical symptoms include fatigue, headache, back pain, breast pain, etc., swelling of the hands and feet, swelling of the stomach, muscle pain, and in some cases, a morbid desire to eat salty or sweet foods.

However, the cause of premenstrual syndrome is not known with certainty, but changes in serotonin secretion secreted during depression according to the menstrual cycle have been identified as one factor. In addition, it is known to occur frequently in women who lack minerals such as magnesium and manganese or vitamin E. Eating a lot of sweet food can lead to severe emotional changes and fatigue, and consuming a lot of caffeine can make restlessness symptoms worse.

A bigger problem is that PMS lasts for a very long time and can afflict women. It is known that some women experience recurrences of PMS symptoms before each menstrual cycle and that these patterns persist until menopause, and that women with PMS or PMS are at greater risk of developing depression.

If premenstrual syndrome gets severe, it can cause serious disorders in daily life, so professional management and treatment are essential. However, there is a tendency to take premenstrual syndrome for granted and overlook the seriousness of the disease or seek solutions based on physical symptoms. In Korea, 1 out of 3 women experience premenstrual syndrome, and 80% of them are affected by it in their daily lives, but most do not receive professional treatment. Only 10% of Korean women suffering from premenstrual syndrome visit a doctor, and only 6% of Korean women take medication to improve menstrual syndrome symptoms, and the medications they are taking are mainly pain relievers or vitamins. is only a reality.

Korean Patent Laid-open Publication No. 10-2021-0086246 (published on July 8, 2021, title of invention: "Digital device and application for treating mild cognitive impairment and dementia") is for mild cognitive impairment (MCI) and / Or based on the mechanism of action (MOA) and treatment hypothesis for dementia, create a digital therapeutic module for the treatment of the mild cognitive impairment and the dementia, and use the digital therapeutic module Mild cognitive impairment comprising a digital task generating unit that generates a specific digital task based on the digital task and provides the digital task to a first user, and a result collection unit that collects a result of the first user's performance on the digital task; and Disclosed is a digital device for the treatment of dementia, which derives pathogenesis, treatment hypotheses, and digital treatment hypotheses in consideration of amnestic mild cognitive impairment and neurological factors in the progression of Alzheimer's disease. By presenting digital tasks and collecting and analyzing the performance results, it is possible to suppress the progression of amnestic mild cognitive impairment and Alzheimer's disease and provide improved therapeutic effects.

However, these devices are specialized for the treatment of mild cognitive impairment and dementia, and cannot be used to diagnose and treat menstrual disorders, which are representative gynecological diseases.

Therefore, there is an urgent need for a technology that can analyze symptoms of menstrual disorder patients through smartphone applications and smart devices, predict and evaluate menstrual disorders, and alleviate symptoms through behavioral treatment and medication guidance.

An object of the present invention is to analyze the symptoms of menstrual disorders for patients with menstrual disorders through smartphone applications and smart devices, to predict and evaluate menstrual disorders, and to provide a method for alleviating symptoms through behavioral treatment and medication guidance. is to do

In addition, an object of the present invention is to divide menstrual disorder patients into patients who need to come to the hospital and patients who do not need to visit depending on the severity, to provide self-therapy in the former case, and to provide medical medication through more precise diagnosis in the latter case It is to provide a digital treatment for predicting and managing menstrual disorders, providing prescriptions or surgical prescriptions.

One aspect of the present invention for achieving the above objects relates to a method for predicting and managing menstrual disorders. The method according to the present invention comprises the steps of receiving state information about the patient's physical state and psychological state related to the patient's menstrual disorder measured and collected by a digital smart device; Collecting and analyzing the received condition information by a menstrual disorder prediction and evaluation unit, and predicting or evaluating whether or not the patient has menstrual disorder and the severity of the menstrual disorder according to the analysis result; And when the patient is predicted or evaluated to have menstrual disorder by the customized therapy generator, menstrual disorder is managed by creating a customized therapy for each patient according to the severity of the menstrual disorder and providing it to the digital smart device. Including the step of generating the therapy and providing it to the digital smart device, when the severity of the menstrual disorder is relatively low, providing self-therapy that patients with menstrual disorders can practice without visiting a medical institution thing; If the severity of the menstrual disorder is relatively high, predicting or evaluating additionally the menstrual disorder of a patient visiting a medical institution, and prescribing medical medication guidance or surgical operation in addition to the self-therapy; and modifying the customized therapy for each patient by monitoring the practice rate indicating the extent to which the patient practices self-therapy and medication guidance and the degree of improvement of menstrual disorder recorded by the digital smart device. In particular, the condition information includes the patient's body mass index (BMI), vital signs including blood pressure, pulse, and electrocardiogram, menstrual data, menstrual volume, premenstrual syndrome (PMS) symptoms, ovulation date, information on physical condition including at least one of eating behavior and water intake; and information on a psychological state including at least one of a patient's depression level, anxiety level, and stress level. In addition, the step of predicting or evaluating whether the patient has menstrual disorder and the severity of menstrual disorder may include storing accumulated data of the patient's condition information; obtaining real-time status information about the patient; and predicting or evaluating the patient's menstrual disorder and its severity based on the accumulated data and real-time status information. Preferably, the step of predicting or evaluating whether the patient has menstrual disorder and the severity of menstrual disorder is the patient's weight, body mass index (BMI), blood pressure, body temperature, electrocardiogram (ECG/EKG), electromyography (EMG) ), photoplethysmography (PPG), heart rate (HR), heart rate variability (HRV), respiratory rate (RR), and skin perfusion to predict the patient's ovulation period and menstrual cycle. include Furthermore, the step of predicting or evaluating whether the patient has menstrual disorder and the severity of menstrual disorder is a Dutch Eating Behavior Questionnaire (DEBQ), a dysmenorrhea questionnaire (MDQ), and a dysmenorrhea scale (Visual Analog Scale; VAS), Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS), MINI-Plus (MINI International Neuropsychiatric Interview-Plus) 5.0.0, Hamilton Rating Scale for Depression; HAM-D), Spielberger State-Train Anxiety Inventory (STAI), Korean Mental Disorder Inventory (K-MDI), Center for Epidemiologic Studies Depression Scale (CES-D), At least one of the Perceived Stress Scale (PSS) and the Scale for Suicidal Ideation (SSI) are utilized. Preferably, the self-therapy includes psychological therapy including at least one of diet therapy, exercise therapy, yoga therapy, release therapy, and breathing therapy; and physical therapy including at least one of music therapy, cognitive-behavioral therapy, and art therapy. In addition, the menstrual disorder is premenstrual syndrome, menstrual irregularity, and menstrual dysphoric disorder (PMDD) predicted or evaluated from the condition information measured through the digital smart device and the symptom record input by the patient; dysmenorrhea predicted or evaluated from a symptom record entered by the patient; and at least one of menorrhagia predicted or evaluated from the amount of menstruation input through the IoT weighing scale.

Another aspect of the present invention for achieving the above objects relates to a digital therapeutic for predicting and managing menstrual disorders. A digital therapeutic agent for predicting and managing menstrual disorders according to the present invention includes a state information receiving unit for receiving state information on the patient's physical state and psychological state related to the patient's menstrual disorder measured and collected by a digital smart device; a menstrual disorder prediction and evaluation unit that collects and analyzes the received condition information, and predicts or evaluates whether or not the patient has menstrual disorder and the severity of the menstrual disorder according to the analysis result; And if the patient is predicted or evaluated to have a menstrual disorder, a menstrual disorder management unit for managing the menstrual disorder by creating a customized therapy for each patient for the menstrual disorder according to the severity of the menstrual disorder and providing it to the digital smart device And, the menstrual disorder prediction and evaluation unit provides self-therapy that patients with menstrual disorders can practice without visiting a medical institution when the severity of menstrual disorders is relatively low, and the severity of menstrual disorders is relatively high. It additionally predicts or evaluates menstrual disorders of patients who visit medical institutions, prescribes medical medication medication guidance or surgical surgery in addition to the self-therapy, and provides self-therapy and medication medication guidance recorded by the digital smart device. It is configured to modify the customized therapy for each patient by monitoring the practice rate indicating the degree of practice and the degree of improvement of menstrual disorder. In particular, the condition information includes the patient's body mass index (BMI), vital signs including blood pressure, pulse, and electrocardiogram, menstrual data, menstrual volume, premenstrual syndrome (PMS) symptoms, ovulation date, information on physical condition including at least one of eating behavior and water intake; and information on a psychological state including at least one of a patient's depression level, anxiety level, and stress level. In addition, the menstrual disorder prediction and evaluation unit stores accumulated data of the patient's condition information, obtains real-time condition information about the patient, and determines whether or not the menstrual disorder and severity of the patient are based on the accumulated data and real-time condition information. It is further configured to predict or evaluate. Preferably, the menstrual disorder prediction and evaluation unit patient's weight, body mass index (BMI), blood pressure, body temperature, electrocardiogram (ECG / EKG), electromyography (EMG), photoplethysmography (PPG), heart rate (HR), heart rate It is further configured to predict an ovulation period and menstrual cycle of the patient using at least one of HRV, respiratory rate (RR), and skin perfusion. In addition, the menstrual disorder prediction and evaluation unit, the Dutch Eating Behavior Questionnaire (DEBQ), the Menstrual Distress Questionnaire (MDQ), the Visual Analog Scale (VAS), and the Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS), MINI-Plus (MINI International Neuropsychiatric Interview-Plus) 5.0.0, Hamilton Rating Scale for Depression (HAM-D), Spielberger State-Train Anxiety Scale Inventory; STAI), Korean Mental Disorder Inventory (K-MDI), Center for Epidemiologic Studies Depression Scale (CES-D), Perceived Stress Scale (PSS), and suicidal ideation It is configured to utilize at least one of the Scale for Suicidal Ideation (SSI). In particular, the self-therapy includes psychological therapy including at least one of diet therapy, exercise therapy, yoga therapy, relaxation therapy, and breathing therapy; and physical therapy including at least one of music therapy, cognitive-behavioral therapy, and art therapy. Preferably, the menstrual disorder is premenstrual syndrome, menstrual irregularity and dysmenorrhea disorder (PMDD) predicted or evaluated from condition information measured through the digital smart device and symptom record input by the patient; dysmenorrhea predicted or evaluated from a symptom record entered by the patient; and at least one of menorrhagia predicted or evaluated from the amount of menstruation input through the IoT weighing scale.

According to the present invention, it is possible to analyze symptoms of menstrual disorders through smart phone applications and smart devices, predict and evaluate menstrual disorders, and alleviate symptoms through behavioral treatment and medication guidance.

In addition, according to the present invention, menstrual disorder patients are divided into patients who need to come to the hospital and patients who do not need to visit depending on the severity, and in the former case, self-therapy is provided, and in the latter case, more precise diagnosis through medical medication Menstrual disorders can be managed by providing prescriptions or surgical prescriptions.

1 is a flowchart schematically illustrating a method for predicting and managing menstrual disorders according to an aspect of the present invention.

FIG. 2 is a diagram briefly illustrating the operation process of the method for predicting and managing menstrual disorders of FIG. 1 .

FIG. 3 is a diagram illustrating differently the operation process of the method for predicting and managing menstrual disorders of FIG. 2 .

4A and 4B are diagrams illustrating a process in which data input by a patient to an application is used for predicting and managing menstrual disorders.

5 is a diagram illustrating a process in which biometric information and input data of a patient are used to predict and manage menstrual disorders.

6 shows diagnosis and treatment guidelines for menstrual disorders published by the Korean Society of Obstetrics and Gynecology.

7 is a block diagram schematically illustrating an operating environment of a digital therapeutic agent for predicting and managing menstrual disorders according to another aspect of the present invention.

In order to fully understand the present invention and its operational advantages and objectives achieved by the practice of the present invention, reference should be made to the accompanying drawings illustrating preferred embodiments of the present invention and the contents described in the accompanying drawings.

Hereinafter, the present invention will be described in detail by describing preferred embodiments of the present invention with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and is not limited to the described embodiments. And, in order to clearly describe the present invention, parts irrelevant to the description are omitted, and the same reference numerals in the drawings indicate the same members.

1 is a flow diagram schematically illustrating a method 100 for predicting and managing menstrual disorders in accordance with one aspect of the present invention.

Since it is not possible to accurately determine the cause of menstrual disorders, the method 100 for predicting and managing menstrual disorders utilizes various condition information as will be described later. In addition, since various causes cause menstrual disorders, the method for predicting and managing menstrual disorders predicts and evaluates menstrual disorders by identifying the patient's symptoms and lifestyle, examining past medical history, and referring to medications taken. . Of course, a physical examination and a pelvic examination may be performed to remove factors affecting menstrual disorders. Through this physical examination, low thyroid hormone (hypothyroidism) or tumors in the breast, brain, or ovary can be found, and through blood tests, medical conditions such as hypoglycemia, hypothyroidism, or other hormonal problems that cause symptoms It is also necessary to examine whether this is a factor.

In the present specification, menstrual disorder refers to premenstrual syndrome, menstrual irregularity, and menstrual dysphoric disorder (PMDD), which are predicted or evaluated from condition information measured through a digital smart device and symptom records input by the patient, input by the patient. It is a broad concept that includes dysmenorrhea predicted or evaluated from a symptom record, and menorrhagia predicted or evaluated from the amount of menstruation input through the IoT weighing scale.

Referring to Figure 1, in order to predict and evaluate menstrual disorders, using a digital smart device to measure and collect state information on the patient's physical condition and psychological state related to the patient's menstrual disorders. Then, the state information receiving unit of the digital therapeutic agent for predicting and managing menstrual disorders receives the collected state information (S110).

The state information to be measured and collected may include information on the patient's physical state and psychological state. For example, information about physical condition may include the patient's body mass index (BMI), vital signs including blood pressure, pulse, and electrocardiogram, menstrual data, menstrual flow, premenstrual syndrome (PMS) symptoms , ovulation day, eating behavior, and water intake, and information on the psychological state may include the patient's depression, anxiety, and stress levels.

When the patient's condition information is received, the menstrual disorder prediction and evaluation unit included in the digital therapeutic agent for predicting and managing menstrual disorders collects and analyzes the received condition information, and determines whether the patient has menstrual disorders or not and The severity of menstrual disorders is predicted or evaluated (S120).

All known techniques can be used to predict or evaluate menstrual disorders using the patient's physical condition and psychological condition.

For example, menstrual irregularity can be evaluated based on biosignal information obtained using a digital smart device such as a smart watch and information directly entered by a patient, and dysmenorrhea based on information directly entered by the patient on the digital smart device. can be evaluated. In addition, by measuring menstrual blood through an IoT weighing scale, it is possible to evaluate whether or not there is excessive menstruation, and it is possible to predict and evaluate menstrual disorders based on biosignal information obtained using a digital smart device and information directly entered by the patient.

Such a menstrual disorder diagnosis technique will be additionally described in the relevant part of the present specification, and therefore, repetitive descriptions are omitted for simplicity of the specification.

In the method 100 for predicting and managing menstrual disorders according to the present invention, the patient is treated differently according to severity. That is, it is determined whether the severity exceeds a predetermined level (S130), and if the severity does not exceed a predetermined level, the menstrual disorder management unit of the digital therapeutic agent for predicting and managing menstrual disorders can practice menstrual disorder patients without visiting a medical institution. A possible self-therapy is created and provided (S140).

On the other hand, if the severity of menstrual disorder is relatively high, the menstrual disorder prediction and evaluation unit additionally predicts or evaluates the menstrual disorder of the patient visiting the medical institution, and the menstrual disorder management unit provides medical medication guidance or surgical treatment in addition to self-therapy. Surgery may be prescribed (S150).

Since menstrual disorders cannot be cured with one or two treatments, it is necessary to improve eating habits, supplement vitamins and minerals such as calcium and magnesium, and exercise prescriptions such as regular exercise to manage menstrual disorders. Yes (see reference [3]). In addition, if the symptoms are severe, psychiatric counseling is required. Therefore, as a therapy for menstrual disorders, all techniques known to be able to treat menstrual disorders can be used.

For example, cognitive-behavioral therapy can be performed using a smartphone application and a smart watch, exercise prescription and dietary therapy can be guided, and a patient can write a symptom diary using a smartphone application. In addition, the patient's medication may be managed by utilizing a medication guidance application installed in the smartphone.

Such a treatment method will be additionally described in the corresponding part of the present specification, and therefore, repetitive description is omitted for simplicity of the specification.

In addition, the method 100 for predicting and managing menstrual disorders according to the present invention does not perform a one-time diagnosis and prescription, but indicates the degree to which a patient practices self-therapy and medication guidance recorded by a digital smart device. The practice rate and the degree of improvement of menstrual disorders are continuously monitored (S160). Referring to the monitored results, the menstrual disorder management unit can effectively control and manage menstrual disorders by modifying and providing customized therapy for each patient (S170).

FIG. 2 is a diagram briefly illustrating the operation process of the method for predicting and managing menstrual disorders of FIG. 1 .

Referring to FIG. 2, when condition information measured from a patient is transmitted to a digital therapeutic agent for predicting and managing menstrual disorders, the digital therapeutic agent determines whether or not menstrual disorders exist and determines menstrual disorders based on the received condition information and the information input by the patient. Assess severity. The evaluated results are used to create patient-specific treatment.

In addition, digital therapeutics for predicting and managing menstrual disorders can improve the performance of predicting and managing menstrual disorders by consulting professional personnel such as doctors. As mentioned above, the physician can continuously monitor the patient's condition.

The customized prescription for each patient created in this way may be referred to as a 'digital therapeutic agent' in this specification.

FIG. 3 is a diagram illustrating differently the operation process of the method for predicting and managing menstrual disorders of FIG. 2 .

As shown in FIG. 3 , state information measured through a wearable device such as a smart watch worn by a patient and an IoT weighing scale may be transmitted to a mobile application. Mobile applications can store data and keep data safe by linking with cloud services.

This status information is used to evaluate and manage menstrual disorders, and in this process, expert medical staff can provide advice (see reference [4]).

In addition, a prediction and evaluation algorithm through machine learning may be used to evaluate menstrual disorders.

Machine learning (ML) means optimizing parameters through given data or experience in a mathematical model composed of multiple parameters. To this end, machine learning first classifies a large number of given data into similar ones in the absence of any prior information, and then extracts cluster features using an algorithm. Then, the algorithm structure built in the previous step is piled up to create a more complex hierarchical structure, and by repeating this process thousands of times, it finds the most optimized algorithm system by itself. These machine learning techniques are combined with big data to broaden the scope of application, and efforts are continuously made to increase the probability and reduce the error for prediction success.

Depending on the shape of the learning problem, machine learning can be divided into supervised machine learning, unsupervised machine learning, and reinforcement learning. It is a learning method to find an output suitable for a given input using data with values and corresponding output values. In addition, unsupervised machine learning is a learning method that finds the regularity of inputs using training data with only input values, and reinforcement type machine learning is an optimal action rather than an output (correct action) for a given input (a given state). Indicates how to choose

As such, in the method for predicting and managing menstrual disorders according to the present invention, since machine learning techniques can be used to predict and evaluate menstrual disorders, evaluation accuracy is improved.

4A and 4B are diagrams illustrating a process in which data input by a patient to an application is used for predicting and managing menstrual disorders.

In FIGS. 4A and 4B , when a patient registers or logs in to the application, My Page, which collectively displays patient information, is displayed. My Page may include a history of information directly input by a patient, such as the date of ovulation or menstruation, and such history may be managed in the form of a diary. In addition, on My Page, health data provided to patients or recommended therapies may be displayed.

Patients can record the symptoms of menstrual disorders they experience and record the amount of food or fluid they have consumed on My Page. In addition, psychological state information such as depression and nervousness can be recorded.

The status information entered by the user can be used for self-diagnosis of menstrual disorders through the self-diagnosis function provided by the application, or can be delivered to a digital treatment for predicting and managing menstrual disorders and used to create more precise evaluations and prescriptions. .

Returning to FIG. 1 again, the step of predicting or evaluating whether the patient has menstrual disorder and the severity of menstrual disorder (S120) stores accumulated data of the patient's condition information and obtains real-time condition information about the patient. and predicting or evaluating the patient's menstrual disorder and its severity based on the accumulated data and real-time status information. That is, the patient's dysmenorrhea is predicted and evaluated in consideration of both the accumulated patient's state history information and the patient's real-time state information.

In the method for predicting and managing menstrual disorders, the condition information used to predict whether a patient has menstrual disorders and the severity of menstrual disorders is the patient's weight, body mass index (BMI), blood pressure (Reference [5] ]), body temperature, electrocardiogram (ECG/EKG), electromyogram (EMG), photoplethysmogram (PPG), heart rate (HR), heart rate variability (HRV), respiratory rate (RR), and skin perfusion, etc. can include In addition, this information can be used to predict the patient's ovulation period and menstrual cycle. For example, through a study conducted on 237 Swiss women who wanted to conceive, they predicted the timing of ovulation by wearing a bio-signal measuring bracelet and measured the bio-signals (body temperature, pulse, respiratory rate, etc.) that change during ovulation through the bracelet. It can be received and analyzed through a measurement algorithm, and the time of ovulation can be identified from the analysis result. To this end, it can be determined that ovulation is closer as the increase in the resting pulse rate, the increase in body temperature, and the increase in pulse rate variability are greater.

That is, it is possible to accurately predict the menstrual cycle by measuring biosignals generated in the body in real time and using an algorithm for changes in biosignals appearing in the menstrual cycle. If the deviation of the predicted menstrual cycle is large, menstrual irregularity may be predicted. For example, as a result of a study targeting healthy women, ovulation can be predicted when there is a difference between the mean pulse rate and the RR interval as a result of measuring changes in the electrocardiogram during the luteal phase for 24 hours.

In addition, it is possible to predict whether a patient suffers from anemia by using blood pressure and an optical sensor. Through this, it is possible to detect anemia due to menorrhagia.

5 is a diagram explaining a patient's biometric information and input data, and a process used for predicting and managing menstrual disorders.

5, when the user's physical state information and psychological state information are collected from the digital smart device, these data are used to evaluate and analyze the cause of menstrual disorder in a digital therapeutic agent for predicting and managing menstrual disorder. In particular, psychological state information can be directly input by the user using a digital smart device. As described above, both accumulated historical data and real-time data may be used in this diagnosis process.

If menstrual disorder and its severity are predicted and evaluated, self-therapy is provided or medication guidance is provided according to the severity.

Specifically, the following may be used to obtain user's physical state information and psychological state information.

- Dutch Eating Behavior Questionnaire (DEBQ)

- Menstrual Distress Questionnaire (MDQ)

- Dysmenorrhea Scale (Visual Analog Scale; VAS)

- Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS)

- MINI-Plus (MINI International Neuropsychiatric Interview-Plus) 5.0.0

- Hamilton Rating Scale for Depression (HAM-D)

- State Trait Anxiety Inventory (STAI)

- Korean Mental Disorder Inventory (K-MDI)

- Center for Epidemiologic Studies Depression Scale (CES-D)

- Perceived Stress Scale (PSS)

- Scale for Suicidal Ideation (SSI).

Among them, the dysmenorrhea questionnaire includes six categories of pain, poor concentration, behavioral change, autonomic nervous system response, water accumulation, and negative emotion, and each symptom ranges from 1 point of 'no symptoms at all' to 'very severe'. It is displayed on a 5-point scale up to 5 points.

State anxiety used in the state trait anxiety scale is to measure the temporary emotional state caused by tension, worry, fear, etc. in a special situation, and trait anxiety is a factor that determines individual differences in coping with external threats. Among them, state anxiety can change in degree over time, but trait anxiety shows a constant pattern throughout life.

In addition, the suicide ideation scale is a test to evaluate various self-destructive thoughts and desires, and the higher the score, the higher the risk of suicide.

It should be noted that these scales are illustrated for convenience of understanding and do not limit the present invention.

When the patient's menstrual disorder is predicted and evaluated, a customized therapy for each patient is created based on the diagnosis result.

6 shows diagnosis and treatment guidelines for menstrual disorders issued by the Korean Society of Obstetrics and Gynecology.

Various treatment methods as introduced in FIG. 6 should be considered in order to provide customized therapy for each patient.

Examples of therapies that can be applied at this time include the following (see references [6], [7], [8], [9]).

- Psychological therapy, including diet therapy, exercise therapy, yoga therapy (see Ref. [2]), release therapy, breathing therapy, etc.

- Physical therapy including music therapy, cognitive-behavioral therapy, art therapy, etc.

It should be noted that these therapies are exemplified for convenience of understanding and do not limit the present invention.

As such, in the method for predicting and managing menstrual disorders according to the present invention, the application, smart watch, and IoT weighing scale are interlocked to collect patient condition information and clinical information, and predictive and evaluation algorithms through machine learning Based on this, it is possible to self-diagnose the patient's menstrual disorders (irregular menstruation, dysmenorrhea, hypermenorrhea, premenstrual syndrome). In addition, the method for predicting and managing menstrual disorders according to the present invention can provide cognitive behavioral therapy and medication guidance to patients using a mobile app and a smart watch based on the diagnosed results.

As an example of medication guidance, the following two therapies may be suggested depending on whether the menstrual cycle is regular.

- If the menstrual cycle is regular, NSAIDs are administered (menstrual pain control) every 8 hours from 2 to 3 days before menstruation begins, and Tranexamic acid is taken every 8 hours at the start of menstruation.

- If the menstrual cycle is irregular, predict the start of menstruation through menstrual pattern analysis and administer it, or take it when pain starts according to the menstrual cycle.

Furthermore, in the method for predicting and managing menstrual disorders of the present invention, the treatment effect on the target disease can be confirmed by monitoring whether symptoms are relieved through a patient management web program.

Cognitive behavioral therapy for patients with menstrual disorder helps relieve symptoms of premenstrual syndrome, and exercise guidance, symptom diary writing, and dietary therapy through the application are expected to help improve menstrual irregularity, dysmenorrhea, and hypermenorrhea symptoms. .

The following research results can be referred to for this therapy.

- 85 normal weight women and 25 overweight or obese women suffering from premenstrual syndrome were evaluated for blood tests, degree of menstrual syndrome, pain, etc., and the factors affecting premenstrual syndrome were investigated. Associated with calcium and vitamin B6.

- As a result of a meta-analysis of 29 studies to see the relationship between primary dysmenorrhea and ginger intake, taking 750 - 2000 mg of ginger powder for 3-4 days after the onset of menstruation is helpful for primary dysmenorrhea.

- Nutrient supplementation (calcium, vitamin B6) and depression and stress management help alleviate premenstrual syndrome.

- Carbohydrate-rich food intake can increase the secretion of serotonin, thereby alleviating the symptoms of premenstrual syndrome.

Additionally, behavioral therapy may include:

- Keeping a Symptom Diary will help you find the right time to deal with worsening symptoms. Minimizing stress during this time and removing factors that exacerbate symptoms can also help treat menstrual disorders.

- In patients with menstrual disorders, sleep disorders ranging from insomnia to excessive sleep are common, so Regular Sleeping Habit is helpful. Therefore, it is necessary to have a habit of taking a planned regular sleep, and it is especially recommended during the luteal phase. Drinking alcohol can adversely affect sleep, so it is best to avoid it.

- Diet Restriction and Exercise: Reducing salt intake can reduce abdominal bloating, water retention, breast bloating and pain, and limiting caffeine intake can reduce premenstrual irritability and insomnia. Small, frequent meals help relieve digestive symptoms, and exercise is also effective.

It should be noted that these therapies are provided for convenience of understanding and do not limit the present invention.

7 is a block diagram schematically illustrating an operating environment of a digital therapeutic agent 750 for predicting and managing menstrual disorders according to another aspect of the present invention.

Referring to FIG. 7 , a digital therapeutic agent 750 for predicting and managing menstrual disorders includes a state information receiver 760, a menstrual disorder prediction and evaluation unit 770, and a menstrual disorder management unit 780. In this specification, the term 'digital remedy' does not mean a simple chemical drug, but provides information stored in the cloud, evaluation results provided by specialized medical institutions, and customized therapy for each patient through an application installed on a smart device. It refers to a service or system that receives and controls menstrual disorders by practicing customized therapy for each patient according to the received message. According to the present invention, the patient can transmit various information used to evaluate menstrual disorders to the server through his or her own smart device, and can easily grasp the customized therapy provided by the server to control menstrual disorders. The process is very similar to patients carrying and taking medications to alleviate their symptoms. Therefore, according to the present invention, a service or system that predicts and evaluates menstrual disorders, provides personalized therapy, and continuously monitors the patient's practice rate and severity level can be referred to as a digital therapeutic agent.

The digital smart device (710, 720, 730) collects state information on the patient's physical condition and psychological state related to the patient's menstrual disorder, and through the network (790), a digital therapeutic agent (750) for predicting and managing menstrual disorder ) is sent to

The digital smart device possessed by the patient may be implemented as a computer capable of accessing the digital therapeutic agent 750 for predicting and managing menstrual disorders through the network 790, for example, a laptop or a laptop equipped with a web browser. etc. may be included. For example, as a wireless communication device that ensures portability and mobility, PCS (Personal Communication System), GSM (Global System for Mobile communications), PDC (Personal Digital Cellular), PHS (Personal Handyphone System), PDA (Personal Digital Assistant) ), International Mobile Telecommunication (IMT)-2000, Code Division Multiple Access (CDMA)-2000, W-Code Division Multiple Access (W-CDMA), Wireless Broadband Internet (Wibro) terminal, smartphone, smart pad ( All kinds of handheld-based wireless communication devices such as smartpads, tablet PCs, and the like can be used as digital smart devices.

When the status information is received, the menstrual disorder prediction and evaluation unit 770 collects and analyzes the received condition information, and predicts or evaluates whether or not the patient has menstrual disorder and the severity of the menstrual disorder according to the analysis result. As described above, various state information of the user can be used in this process. In addition, the menstrual disorder prediction and evaluation unit 770 may improve prediction and diagnosis accuracy by utilizing machine learning techniques as described above.

When the menstrual disorder prediction and evaluation unit 770 predicts or evaluates that the patient has menstrual disorder, the menstrual disorder management unit 780 generates a customized therapy for each patient according to the severity of the menstrual disorder and digitally Provided to smart devices (710, 720, 730). At this time, the menstrual disorder management unit 780 provides self-therapy that the menstrual disorder patient can practice without visiting a medical institution when the severity of the menstrual disorder is relatively low, and the severity of the menstrual disorder is relatively high. Menstrual disorders of patients visiting a medical institution may be additionally predicted or evaluated, and medical medication guidance or surgical operation may be prescribed in addition to the self-therapy.

Furthermore, the menstrual disorder management unit 780 monitors the practice rate and the degree of improvement of menstrual disorder, which are recorded by the digital smart devices 710, 720, and 730, indicating the degree to which the patient practices self-therapy and medication guidance, for each patient. It is configured to modify the custom therapy. In this way, the menstrual disorder management unit 780 refers not only to past history data of the patient but also to data after the customized therapy for each patient is provided in order to create a customized therapy for each patient. Accordingly, the degree of suitability of the therapy customized for each patient to the patient can be improved.

According to the present invention, it is possible to diagnose menstrual disorders by analyzing through an algorithm using vital signs obtained from women and evaluation measurement tools (survey, menstrual diary, etc.) For this, customized therapies for each patient, such as dietary therapy and behavioral therapy, can be suggested. In addition, it is possible to accurately predict menstrual disorders (irregular menstruation, dysmenorrhea, hypermenorrhea, premenstrual syndrome, etc.) by using apps and digital smart devices.

According to the present invention, since it becomes possible to predict and manage a class (student, head of a household, shift workers) who have difficulty visiting a hospital, it can contribute to women's welfare. In particular, considering the situation in which people are extremely reluctant to visit a hospital due to gynecological diseases, the treatment effect according to the present invention is more expected.

In addition, according to the present invention, by analyzing the data obtained through the consent of women, it is possible to grasp the current status of menstrual disorders in Korea and to obtain a systematic approach to women's health that can overcome the era of low fertility.

Finally, since the patient's condition information and questionnaire results can be collected without the need to visit the hospital, hidden patient groups that require accurate evaluation and management and patient groups that require pre-pregnancy correction can be discovered in advance, which can cause infertility. Diseases can be predicted, managed and prevented in advance.

Although the present invention has been described with reference to the embodiments shown in the drawings, this is only exemplary, and those skilled in the art will understand that various modifications and equivalent other embodiments are possible therefrom.

In addition, the method according to the present invention can be implemented as computer readable codes on a computer readable recording medium. A computer-readable recording medium may include all types of recording devices storing data that can be read by a computer system. Examples of computer-readable recording media include ROM, RAM, CD-ROM, magnetic tape, floppy disk, and optical data storage devices, and also those implemented in the form of carrier waves (for example, transmission through the Internet). include In addition, the computer-readable recording medium may store computer-readable codes that can be executed in a distributed manner by distributed computer systems connected through a network.

In the terms used in this specification, singular expressions should be understood to include plural expressions unless clearly interpreted differently in context, and terms such as “comprising” refer to the described features, numbers, steps, operations, and components. , parts or combinations thereof, but it should be understood that it does not exclude the possibility of the presence or addition of one or more other features or numbers, step-action components, parts or combinations thereof. In addition, terms such as "... unit", "... unit", "module", and "block" described in the specification mean a unit that processes at least one function or operation, which is hardware, software, or hardware. And it can be implemented as a combination of software.

Therefore, this embodiment and the drawings accompanying this specification clearly represent only a part of the technical idea included in the present invention, and those skilled in the art can easily understand it within the scope of the technical idea included in the specification and drawings of the present invention. It will be obvious that all variations and specific examples that can be inferred are included in the scope of the present invention.

<References>

[1] Ryu A, Kim TH. Premenstrual syndrome: A mini review. Maturitas [Internet]. 2015;82(4):436-40.

[2] Yang N. Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Trial. J Altern Complement Med. 2016;22(9):732-8.

[3] Choi DS. Guidelines for Clinical Management of Premenstrual Syndrome. J Korean Med Assoc. 2005;48(5):465.

[4] Goodale BM, Shilaih M, Falco L, Dammeier F, Hamvas G, Leeners B. Wearable sensors reveal menses-driven changes in physiology and enable prediction of the fertile window: Observational study. J Med Internet Res. 2019;21(4).

[5] Dunne FP, Barry DG, Ferriss JB, Grealy G, Murphy D. Changes in blood pressure during the normal menstrual cycle. Clin Sci. 1991 Oct 1;81(4):515-8

[6] Endres S, Mayuga KA, De Cristofaro A, Taneja T, Goldberger JJ, Kadish AH. Menstrual cycle and ST height. Ann Noninvasive Electrocardiol. 2004;9(2):121-6.

[7] Petrozzi MJ, Leaver A, Ferreira PH, Rubinstein SM, Jones MK, Mackey MG. Addition of MoodGYM to physical treatments for chronic low back pain: A randomized controlled trial. Chiropractice & Manual Therapies. 2019;27(1):54.

[8] Borenstein JE, Dean BB, Yonkers KA, Endicott J. Using the daily record of severity of problems as a screening instrument for premenstrual syndrome. Obstet Gynecol. 2007;109(5):1068-75.

S, Pach D, Eisenhart-Rothe S von, Lotz F, Roll S, Icke K, et al. Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial. Am J Obstet Gynecol. 2018;218(2):227.e1-227.e9.[9]

S, Pach D, Eisenhart-Rothe S von, Lotz F, Roll S, Icke K, et al. Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial. Am J Obstet Gynecol. 2018;218(2):227.e1-227.e9.

The present invention can be applied to the field of predicting and evaluating menstrual disorders and controlling menstrual disorders according to the results.

Claims (14)

As a method for predicting and managing menstrual disorders, Receiving state information about the patient's physical state and psychological state related to the patient's menstrual disorder measured and collected by the digital smart device; Collecting and analyzing the received condition information by a menstrual disorder prediction and evaluation unit, and predicting or evaluating whether or not the patient has menstrual disorder and the severity of the menstrual disorder according to the analysis result; and When the patient is predicted or evaluated to have menstrual disorder by the customized therapy generator, according to the severity of the menstrual disorder, a customized therapy for each patient is generated and provided to the digital smart device to manage menstrual disorder contains steps, The step of generating the therapy and providing it to the digital smart device, providing self-therapy that patients with menstrual disorders can practice without visiting a medical institution when the severity of menstrual disorders is relatively low; If the severity of the menstrual disorder is relatively high, predicting or evaluating additionally the menstrual disorder of a patient visiting a medical institution, and prescribing medical medication guidance or surgical operation in addition to the self-therapy; and Menstrual disorder characterized in that it includes modifying the customized therapy for each patient by monitoring the practice rate indicating the degree to which the patient practices self-therapy and medication guidance and the degree of improvement of menstrual disorder recorded by the digital smart device How to predict and manage. According to claim 1, The status information is Patient's body mass index (BMI), vital signs including blood pressure, pulse, and electrocardiogram, menstrual data, menstrual volume, premenstrual syndrome (PMS) symptoms, ovulation date, eating behavior, and information about a physical condition including at least one of water intake; and A method for predicting and managing menstrual disorders comprising information on a psychological state including at least one of a patient's depression level, anxiety level, and stress level. According to claim 1, The step of predicting or evaluating whether the patient has menstrual disorder and the severity of menstrual disorder, storing accumulated data of the patient's condition information; obtaining real-time status information about the patient; and A method for predicting and managing menstrual disorders, comprising predicting or evaluating the patient's menstrual disorders and severity based on the accumulated data and real-time status information. According to claim 3, The step of predicting or evaluating whether the patient has menstrual disorder and the severity of menstrual disorder, Patient's weight, body mass index (BMI), blood pressure, body temperature, electrocardiogram (ECG/EKG), electromyogram (EMG), photoplethysmogram (PPG), heart rate (HR), heart rate variability (HRV), respiratory rate (RR), and predicting an ovulation period and menstrual cycle of the patient using at least one of skin perfusion. According to claim 4, The step of predicting or evaluating whether the patient has menstrual disorder and the severity of menstrual disorder, Dutch Eating Behavior Questionnaire (DEBQ), Menstrual Distress Questionnaire (MDQ), Visual Analog Scale (VAS), Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS), MINI International Neuropsychiatric Interview-Plus (MINI-Plus) 5.0.0, Hamilton Rating Scale for Depression (HAM-D), Spielberger State-Train Anxiety Inventory (STAI), Mental Disorder Scale (Korean Among the Mental Disorder Inventory (K-MDI), Center for Epidemiologic Studies Depression Scale (CES-D), Perceived Stress Scale (PSS), and Scale for Suicidal Ideation (SSI) A method for predicting and managing menstrual disorders comprising utilizing at least one. According to claim 1, The self-therapy, psychological therapy including at least one of diet therapy, exercise therapy, yoga therapy, release therapy, and breathing therapy; and A method for predicting and managing menstrual disorders, comprising physical therapy including at least one of music therapy, cognitive-behavioral therapy, and art therapy. According to any one of claims 1 to 6, The menstrual disorder, premenstrual syndrome, menstrual irregularity, and menstrual dysphoric disorder (PMDD) predicted or evaluated from the condition information measured through the digital smart device and the symptom record input by the patient; dysmenorrhea predicted or evaluated from a symptom record entered by the patient; and A method for predicting and managing menstrual disorders, comprising at least one of menorrhagia predicted or evaluated from the amount of menstruation input through the IoT weighing scale. As a digital treatment for predicting and managing menstrual disorders, a state information receiving unit for receiving state information about the patient's physical state and psychological state related to the patient's menstrual disorder, which is measured and collected by the digital smart device; a menstrual disorder prediction and evaluation unit that collects and analyzes the received condition information, and predicts or evaluates whether or not the patient has menstrual disorder and the severity of the menstrual disorder according to the analysis result; and When a patient is predicted or evaluated to have a menstrual disorder, a menstrual disorder management unit for managing the menstrual disorder by creating a patient-specific therapy for the menstrual disorder according to the severity of the menstrual disorder and providing it to the digital smart device, , The menstrual disorder prediction and evaluation unit, If the severity of menstrual disorders is relatively low, provide self-therapy that patients with menstrual disorders can practice without visiting a medical institution, If the severity of the menstrual disorder is relatively high, the menstrual disorder of the patient visiting the medical institution is additionally predicted or evaluated, and in addition to the self-therapy, medical medication guidance or surgical operation is prescribed, Prediction of menstrual disorder, characterized in that it is configured to modify the customized therapy for each patient by monitoring the practice rate, which indicates the degree to which the patient practices self-therapy and medication guidance, and the degree of improvement of menstrual disorder recorded by the digital smart device. A digital therapy for creating and managing. According to claim 8, The status information is Patient's body mass index (BMI), vital signs including blood pressure, pulse, and electrocardiogram, menstrual data, menstrual volume, premenstrual syndrome (PMS) symptoms, ovulation date, eating behavior, and information about a physical condition including at least one of water intake; and A digital therapeutic agent for predicting and managing menstrual disorders, comprising information on a patient's psychological state including at least one of depression, anxiety, and stress levels. According to claim 8, The menstrual disorder prediction and evaluation unit, Store the accumulated data of the patient's condition information, Obtain real-time status information about the patient; A digital therapeutic agent for predicting and managing menstrual disorders, characterized in that it is further configured to predict or evaluate the patient's menstrual disorders and severity based on the accumulated data and real-time status information. According to claim 10, The menstrual disorder prediction and evaluation unit, Patient's weight, body mass index (BMI), blood pressure, body temperature, electrocardiogram (ECG/EKG), electromyogram (EMG), photoplethysmogram (PPG), heart rate (HR), heart rate variability (HRV), respiratory rate (RR), and skin perfusion. According to claim 11, The menstrual disorder prediction and evaluation unit, Dutch Eating Behavior Questionnaire (DEBQ), Menstrual Distress Questionnaire (MDQ), Visual Analog Scale (VAS), Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS), MINI International Neuropsychiatric Interview-Plus (MINI-Plus) 5.0.0, Hamilton Rating Scale for Depression (HAM-D), Spielberger State-Train Anxiety Inventory (STAI), Mental Disorder Scale (Korean Mental Disorder Inventory (K-MDI), Center for Epidemiologic Studies Depression Scale (CES-D), Perceived Stress Scale (PSS), and Scale for Suicidal Ideation (SSI) A digital therapy for predicting and managing menstrual disorders, characterized in that it is configured to utilize at least one. According to claim 8, The self-therapy, psychological therapy including at least one of diet therapy, exercise therapy, yoga therapy, release therapy, and breathing therapy; and A digital therapy for predicting and managing menstrual disorders, characterized in that it includes physical therapy including at least one of music therapy, cognitive-behavioral therapy, and art therapy. According to any one of claims 8 to 13, The menstrual disorder, premenstrual syndrome, menstrual irregularity, and menstrual dysphoric disorder (PMDD) predicted or evaluated from the condition information measured through the digital smart device and the symptom record input by the patient; dysmenorrhea predicted or evaluated from a symptom record entered by the patient; and A digital therapeutic agent for predicting and managing menstrual disorders, characterized in that it includes at least one of menorrhagia predicted or evaluated from the amount of menstruation input through the IoT weighing scale.

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