Empirical study on confirmation and evaluation of temperature changes in the menstrual cycle (biphasic) using wearable devices capable of continuous temperature measurement (developed products) -Verification of reliability, validity, and clinical usefulness of confirmation and evaluation of temperature changes (biphasic) in the menstrual cycle-

UMIN ID: UMIN000054382

Registered date:07/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Female with menstrual cycle
• Date of first enrollment: 2024/06/08
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Confirmation of the feasibility of using abdominal temperature as a method of biphasic confirmation of the menstrual cycle
• Secondary Outcome: (1) Number of days in the high-temperature phase determined from the point of change in abdominal temperature and mouth temperature (2) Correlation coefficient between the typical temperature of the day and the temperature of the mouth (3) Validity as a continuous measurement method (4) Verification of the accuracy of the menstrual cycle prediction model

Key inclusion & exclusion criteria

• Age minimum: 25years-old
• Age maximum: 54years-old
• Gender: Female
• Exclude criteria: 1. Those who are currently attending a gynecological clinic and are undergoing treatment, those who have a history of uterine or ovarian surgery, and those who have a history or current infection of gynecological malignancies such as uterine cancer, ovarian cancer, and breast cancer 2. Those who take oral contraceptives such as pills or other female hormones 3. Those who are unable to participate due to physical or mental health reasons at the discretion of a physician 4. Persons who are unable to obtain consent due to personal circumstances, etc. 5. Those who are judged by the principal investigator to be inappropriate as the subject of this study 6. Those who are unable to communicate in Japanese 7. Those who are unable to connect to their own WIFI when sleeping, in an environment where 4G or 5G communication is not possible 8. Those who are pregnant 9. Those who are likely to become pregnant during the course (excluding sudden ones) * However, if it is found that you are pregnant during participation, you can continue 10. Those who are planning to travel or on a business trip and have to change their sleeping place (excluding sudden ones) 11. Those who work the night shift

Related Information

• Primary Sponsor: Healthcare Systems Co., Ltd.
• Source(s) of Monetary Support: Murata Manufacturing Co., Ltd.