Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060995) titled 'A study to find a method to objectively measure the severity of menstrual pain using a smartwatch' on March 20.

Study Type: Observational

Primary Sponsor: Institute - TechDoctor, Inc.

Condition: Condition - Adult women Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the possibility of developing a digital biomarker for estimating the intensity of menstrual pain in Japanese women Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old = Gender - Female Key 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 Key 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 Target Size - 360

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 26 Day Date of IRB - 2026 Year 03 Month 02 Day Anticipated trial start date - 2026 Year 03 Month 23 Day Last follow-up date - 2027 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069796

Disclaimer: Curated by HT Syndication.