UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049006 |
|---|---|
| Receipt number | R000055829 |
| Scientific Title | Effectiveness of self-management applications for premenstrual syndrome |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2022/09/23 00:37:07 |
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Basic information
Public title
Effectiveness of self-management apps for premenstrual syndrome
Acronym
Effect of PMS apps
Scientific Title
Effectiveness of self-management applications for premenstrual syndrome
Scientific Title:Acronym
Effect of PMS apps
Region
| Japan |
Condition
Condition
premenstrual syndrome
Classification by specialty
| Obstetrics and Gynecology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effectiveness of self-care applications in premenstrual syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency and severity of premenstrual syndrome
Key secondary outcomes
quality of life
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
3 months
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
| 15 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Female
Key inclusion criteria
High school girls who have one or more symptoms of premenstrual syndrome
Key exclusion criteria
Being treated for concomitant menstrual symptoms
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
Zip code
5090293
Address
4-3-3 Nijigaoka, Kani, Gifu, 5090293
TEL
0574656555
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
Zip code
5090293
Address
4-3-3 Nijigaoka, Kani, Gifu, 5090293
TEL
0574656555
Homepage URL
jsei@u-gifu-ms.ac.jp
Sponsor or person
Institute
Gifu university of medical science
Faculty of nursing
Institute
Department
Personal name
Funding Source
Organization
Jinno Institute
Gifu University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University of Medical Science
Address
4-3-3 Nijigaoka, Kani, Gifu, 5090293
Tel
0574656555
jsei@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 | 03 | Month | 31 | 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
| 2022 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 09 | Month | 23 | Day |
Last modified on
| 2022 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055829
