UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063002 |
|---|---|
| Receipt number | R000055133 |
| Scientific Title | An Intervention Study Using a Self-Management Application for Premenstrual Syndrome in Young Women |
| Date of disclosure of the study information | 2026/09/20 |
| Last modified on | 2026/09/20 20:41:53 |
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Basic information
Public title
Intervention study using self-care management application for PMS
Acronym
App for PMS
Scientific Title
An Intervention Study Using a Self-Management Application for Premenstrual Syndrome in Young Women
Scientific Title:Acronym
PMS app intervention
Region
| Japan |
Condition
Condition
premenstrual syndrome
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effectiveness of the PMS self-management app, which can positively record daily symptoms and help you respond to your symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in PMS coping self-efficacy before and after use of the application
Key secondary outcomes
Changes in understanding of PMS symptoms, self-care behaviors, and PMS symptom scores before and after use of the PMS application.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will use the PMS self-management support application 'MOON' for at least two menstrual cycles (approximately 2-3 months). The application enables participants to record and visualize their menstrual cycles and PMS symptoms and provides information on PMS and self-care strategies.
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
| 19 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Women who have never given birth.
2.Women who experience psychological and/or physical symptoms before menstruation that improve or disappear after the onset of menstruation.
3.Women whose premenstrual symptoms have at least some impact on their daily lives.
4.Women who are able to use the 'MOON' application on a smartphone (iOS or Android).
5.Women who are able to use the application and complete the questionnaires in Japanese.
6.Women who understand the study and provide informed consent to participate.
Key exclusion criteria
1.Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
2.Women who are amenorrheic or have markedly irregular menstrual cycles, making it difficult to use the application for at least two menstrual cycles during the study period.
3.Women who are currently receiving medical treatment for premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD).
4.Women who are deemed by the principal investigator to be unsuitable for participation in the study due to their health condition or other reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | JUNGETSU |
| Middle name | |
| Last name | SEI |
Organization
Gifu University of Medical Science
Division name
Faculty of Nursing, Department of Nursing
Zip code
509-0293
Address
4-3-3 Nijigaoka, Kani, Gifu
TEL
0574-65-6555
jsei@u-gifu-ms.ac.jp
Public contact
Name of contact person
| 1st name | JUNGETSU |
| Middle name | |
| Last name | SEI |
Organization
Gifu University of Medical Science
Division name
Faculty of Nursing, Department of Nursing
Zip code
5090293
Address
4-3-3 Nijigaoka, Kani, Gifu
TEL
0574656555
Homepage URL
jsei@u-gifu-ms.ac.jp
Sponsor or person
Institute
Gifu University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japanese Governmental office
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Gifu University of Medical Science
Address
795-1 Nagamine Ichihiraga, Seki, Gifu, 501-3892
Tel
0575-22-9401
kenkyu@u-gifu-ms.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 | 09 | Month | 20 | 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
| 2026 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 09 | Month | 20 | Day |
Last modified on
| 2026 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055133
