UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060368 |
|---|---|
| Receipt number | R000069023 |
| Scientific Title | Investigation of the effects of lower abdominal warming with heat sheets and the associated psychophysiological impact. |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/15 16:39:50 |
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Basic information
Public title
Investigation of the effects of lower abdominal warming with heat sheets and the associated psychophysiological impact.
Acronym
Investigation of the effects of lower abdominal warming with heat sheets and the associated psychophysiological impact.
Scientific Title
Investigation of the effects of lower abdominal warming with heat sheets and the associated psychophysiological impact.
Scientific Title:Acronym
Investigation of the effects of lower abdominal warming with heat sheets and the associated psychophysiological impact.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effects of lower abdominal warming with heat sheets and the associated psychophysiological impact.
Basic objectives2
Others
Basic objectives -Others
To evaluate user experience and perceived effectiveness of continuous lower-abdominal warming.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Perceived effects with and without steam heat sheets
Key secondary outcomes
Investigation of characteristic changes in individuals who experienced benefit from lower-abdominal warming with steam heat sheets.
Changes in body temperature, blood flow, and blood pressure with and without steam heat sheets.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
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).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | 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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Fukagawa |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-070-3297-0978
fukagawa.satoko@kao.com
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Tsunoda |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-070-3296-8210
Homepage URL
tsunoda.mai@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131- 8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069023
