None listed
Conditions
Interventions
In menstrual cycle 1, apply a steam heat sheet to the lower abdomen for 8 hours per day for 7 consecutive days (daily for 7 days, starting 7 days before the expected Day 2 of menstruation). Cycle 2: w
Sponsors
Kao Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
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. Self-reported mild menstrual-associated symptoms (symptoms that do not interfere with daily activities or work).
Exclusion criteria
Exclusion criteria: 1. Currently receiving outpatient care, taking medication for, or with a history of gynecological disorders (e.g., dysmenorrhea, uterine fibroids, adenomyosis, endometriosis, cervical intraepithelial neoplasia, cervical cancer, etc.). 2. Regular use of analgesics (including over-the-counter medications) during the premenstrual or menstrual phase. 3. 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. 4. 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. 5. Receiving hormone replacement therapy (HRT) or taking medications that may affect hormonal status (including oral contraceptives). 6. Pregnant, breastfeeding, or planning to become pregnant during the study period. 7. History of eczema or urticaria induced by steam-heat stimulation. 8. Impaired thermal sensation or hypersensitivity to temperature. 9. Any other condition judged by the principal investigator or study staff to render the participant unsuitable for the study. 10. Participation in another clinical trial of drugs or food products within the past month, or planned participation in such a trial during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual-associated symptoms (pain) according to the duration of steam heat sheet application (7 days, 1 day, no application). | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in menstrual-associated symptoms (non-pain symptoms), and in expressions used to describe pain and perceived effectiveness (subjective descriptors of effect), according to the duration of steam heat sheet application (7 days, 1 day, no application). | — |
Countries
Japan
Contacts
Public ContactMai Tsunoda
Kao Corporation Human Health Care Products Research
Outcome results
None listed