Adult women
Conditions
Interventions
None listed
Sponsors
TechDoctor, Inc.
ASKA Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Premenopausal women aged 18 to 45 years at the time of informed consent (2) Those who can confirm regular menstrual cycles (24-38 day cycle) (3) Those who routinely record menstrual information in a healthcare application (4) Those who own a smartphone capable of installing the wearable device application and can agree to the terms of use regarding the wearable device and application used in the study (5) Those who have provided appropriate written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: (1) Those who have taken oral contraceptives, low-dose estrogen-progestin combinations, progestin preparations, or GnRH analog preparations within 2 months prior to the start of the study (2) Those who have had no menstruation for the past 3 months or more, are pregnant, breastfeeding, or actively desiring to become pregnant during the study period (3) Those using devices or medications that may affect heart rate, such as pacemakers or certain drugs (4) Those with highly irregular sleep rhythms, such as shift workers (5) Those with chronic pain disorders (e.g., chronic migraine or fibromyalgia), poorly controlled severe psychiatric disorders, infectious diseases, or diseases under treatment, making health management difficult (6) Those with symptoms such as eczema, allergies, asthma, or sensitive skin that are prone to dermatitis caused by wearable devices (7) Others judged inappropriate to participate in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimation accuracy of dysmenorrhea score based on biometric data | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory investigations using biometric data, including the following items, will be conducted: (1) Estimation accuracy of pain VAS (2) Estimation accuracy of MDQ score (3) Estimation accuracy of EQ-5D-5L score (4) Prediction accuracy of dysmenorrhea score from the next menstrual cycle onwards (5) Relationship between physical condition records in the app and each questionnaire score | — |
Countries
Japan
Contacts
Public ContactKosaku Kawada
TechDoctor, Inc. Business Development
Outcome results
None listed