Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060368) titled 'Investigation of the effects of lower abdominal warming with heat sheets and the associated psychophysiological impact' on Jan. 15.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kao Corporation

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Investigation of the effects of lower abdominal warming with heat sheets and the associated psychophysiological impact. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In menstrual cycle 1, a steam heat sheet will be applied to the lower abdomen for 8 hours per day for approximately 20 days (from the menstrual phase through the implantation period). Menstrual cycle 2 will be a washout period. Menstrual cycle 3 will have no intervention. Interventions/Control_2 - Menstrual cycle 1 will have no intervention. Menstrual cycle 2 will be a washout period. In menstrual cycle 3, a steam heat sheet will be applied to the lower abdomen for 8 hours per day for approximately 20 days (from the menstrual phase through the implantation period).

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - 1. Females aged 20-49 years. 2. Regular menstrual cycles (cycle length 25-38 days, with month-to-month variability generally within +/-3 days) and able to report the dates/durations of the three most recent menstrual periods. 3. No history of gynecological disorders (e.g., uterine fibroids, adenomyosis, endometriosis, cervical intraepithelial neoplasia, cervical cancer, etc.). Key exclusion criteria - 1. Presence of hepatic, renal, cardiac, respiratory, endocrine, metabolic (e.g., hypertension), neurological disorders, disorders of consciousness, diabetes, or other medical conditions that would preclude participation in the study. 2. Received medication therapy or surgery for a serious illness or injury within one month prior to study initiation and judged by the principal investigator or study staff to be unsuitable for participation. 3. Inability to maintain consistent (unchanged) intake/exercise habits regarding specified health foods, Foods with Function Claims, or dietary supplements (e.g., capsules) from one month prior to study initiation. 4. Participation in another clinical trial of drugs or food products within the past month, or planned participation in such a trial during this study. 5. Non-regular day workers (i.e., those who have night-shift rotations). 6. Receiving hormone replacement therapy (HRT) or taking medications that may affect hormonal status (including oral contraceptives). 7. Routinely applying external warming (e.g., disposable heat packs [kairo]) or receiving acupuncture/moxibustion to sites other than the study site (lower abdomen), or planning to perform such warming during the study period. 8. Pregnant, breastfeeding, or planning to become pregnant during the study period. 9. History of eczema or urticaria induced by heat. 10. Impaired thermal sensation or hypersensitivity to temperature. 11. Known sensitivity to adhesive products (e.g., plasters/bandages) or a history of contact dermatitis from adhesive materials. 12. Any other condition judged by the principal investigator or study staff to render the participant unsuitable for the study. Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 12 Month 05 Day Date of IRB - 2024 Year 12 Month 05 Day Anticipated trial start date - 2025 Year 01 Month 10 Day Last follow-up date - 2025 Year 06 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069023

Disclaimer: Curated by HT Syndication.