UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059580 |
|---|---|
| Receipt number | R000067734 |
| Scientific Title | Examination of the Effects of Temperature in Disposable Heating Pads on Alleviating Menstrual |
| Date of disclosure of the study information | 2025/10/29 |
| Last modified on | 2025/10/29 16:30:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the Effects of Temperature in Disposable Heating Pads on Alleviating Menstrual
Acronym
Examination of the Effects of Temperature in Disposable Heating Pads on Alleviating Menstrual
Scientific Title
Examination of the Effects of Temperature in Disposable Heating Pads on Alleviating Menstrual
Scientific Title:Acronym
Examination of the Effects of Temperature in Disposable Heating Pads on Alleviating Menstrual
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of three types of disposable heating pads with different temperatures for menstrual pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale (VAS)
Key secondary outcomes
McGill Pain Questionnaire(MPQ)
Menstrual Distress Questionnaire(MDQ)
Subjective evaluation (original questionnaire: eight items including sense of warmth, satisfaction, and free comments)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants are instructed to apply one disposable heating pad per day to their lower abdomen, over their undergarments, on days they experienced severe menstrual pain.
Interventions/Control_2
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
Individuals who self-reported severe menstrual pain for at least one day per menstrual period, with a menstrual cycle length of 24-39 days over the past three months.
Key exclusion criteria
1. Individuals with irregular menstruation.
2. Individuals with dysmenorrhea severe enough to require treatment at a medical institution.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Inomata |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Personal & House Care Product Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0179
s.inomata@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Aoi |
| Middle name | |
| Last name | Nohara |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Personal & House Care Product Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0179
Homepage URL
a.nohara@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical Co., Ltd.
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
Nayoro City University Review Committee
Address
1-8, Nishi 4-jo Kita 8-chome, Nayoro, Hokkaido, Japan
Tel
01654-2-4194
minamiyama@nayoro.ac.jp
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
| 2025 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
not published
Publication of results
Published
Result
URL related to results and publications
not published
Number of participants that the trial has enrolled
42
Results
A total of 42 participants enrolled in the study; however, the 30 participants who completed the trial with all three types of disposable heating pads were included in the final analysis.
All three disposable heating pads showed a significant reduction in VAS and total MPQ scores.
Results date posted
| 2025 | Year | 10 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Individuals who self-reported severe menstrual pain for at least one day per menstrual period, with a menstrual cycle length of 24-39 days over the past three months.
Participant flow
The purpose, procedures, and ethical considerations of the study were explained both orally and in writing.
Participants who provided informed consent were given an envelope containing the instruction sheet, questionnaires, and other related materials.
Adverse events
None
Outcome measures
Visual Analog Scale (VAS)
McGill Pain Questionnaire(MPQ)
Menstrual Distress Questionnaire(MDQ)
Subjective evaluation (original questionnaire: eight items including sense of warmth, satisfaction, and free comments)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067734
