UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060225 |
|---|---|
| Receipt number | R000068883 |
| Scientific Title | Development and Evaluation of Educational Program to Promote Health-related Behaviors among Women Aged 18-29 Years Experiencing Menstrual Pain that Disrupts Daily Life: a Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/09 |
| Last modified on | 2025/12/28 22:13:55 |
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Basic information
Public title
Development and Evaluation of Educational Program to Promote Health-related Behaviors among Women Aged 18-29 Years Experiencing Menstrual Pain that Disrupts Daily Life: a Pilot Randomized Controlled Trial
Acronym
Menstrual Pain Study
Scientific Title
Development and Evaluation of Educational Program to Promote Health-related Behaviors among Women Aged 18-29 Years Experiencing Menstrual Pain that Disrupts Daily Life: a Pilot Randomized Controlled Trial
Scientific Title:Acronym
Development and Evaluation of Educational Program for Menstrual Pain: a Pilot Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Menstrual pain
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness of an educational program for promoting health-related behaviors to menstrual pain among women aged 18-29 years who experience disruption in daily life owing to menstrual pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Stage of behavior change regarding gynecological visits after two months
Key secondary outcomes
･Stage of behavior change regarding effective use of analgesics for menstrual pain after two months
･Stage of behavior change regarding self-monitoring of menstrual pain after two months
･Stage of behavior change regarding gynecological visits immediately post-intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
Viewing e-learning materials and browsing materials according to their stage of behavior change.
Interventions/Control_2
Control group
No materials will be provided until the end of the study; after completion, participants will be offered the opportunity to view the materials.
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Women experiencing disruption in daily life owing to menstrual pain
Key exclusion criteria
･History of gynecological visits for menstrual pain
･Ongoing gynecological care
･History of endometriosis, uterine fibroids, adenomyosis, ovarian cysts, and/or secondary dysmenorrhea
･Use of oral contraceptives
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sachie |
| Middle name | |
| Last name | Fujita |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa City, Tokyo, Japan
TEL
03-3819-1211
fujita-sachie@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Sachie |
| Middle name | |
| Last name | Fujita |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa City, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
fujita-sachie@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University Arakawa Campus Research Ethics Committee
Address
Tokyo Metropolitan University Arakawa Campus Research Ethics Committee Secretariat, 7-2-10 Higashi-Ogu, Arakawa City, Tokyo, Japan, 116-8551
Tel
03-3819-1211
a-rinri@jmj.tmu.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
| 2026 | Year | 01 | Month | 09 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 20 | 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 | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068883
