UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054573 |
|---|---|
| Receipt number | R000062360 |
| Scientific Title | Behavior change approach for students with menstrual abnormalities |
| Date of disclosure of the study information | 2024/06/10 |
| Last modified on | 2024/06/05 11:54:58 |
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Basic information
Public title
Behavior change approach for students with menstrual abnormalities: Randomized Controlled Trial
Acronym
HASMA (Health Approach for Students with Menstrual Abnormalities) Study
Scientific Title
Behavior change approach for students with menstrual abnormalities
Scientific Title:Acronym
HASMA (Health Approach for Students with Menstrual Abnormalities) Study
Region
| Japan |
Condition
Condition
Menstrual abnormalities
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a randomized controlled trial, we will use a mobile application to send messages encouraging female students with menstrual abnormalities to see a doctor, and verify its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Changes in the stages of the Transtheoretical Model at 3 and 9 months after the start of the intervention
Key secondary outcomes
At 3 months and 9 months after the start of the intervention, Knowledge of menstruation, Self-efficacy (GSES), Number of the process of change used, Decisional balance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Immediately after allocation, after 3 months, after 9 months, text messages will be delivered that are a combination of 5 messages tailored to menstrual symptoms and 3 messages tailored to the stage of the Transtheoretical Model.
Interventions/Control_2
Immediately after allocation, after 3 months, after 9 months, a non-personalized consultation recommendation leaflet will be distributed.
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
| 20 | years-old | > |
Gender
Female
Key inclusion criteria
First year female students (18-19 years old) who are menstruating and belong to the research institution and have agreed to cooperate with the research.
Key exclusion criteria
Female students over 20 years old.
Pregnant woman.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Yoshiike |
Organization
Aomori University of Health and Welfare
Division name
Graduate School of Health Science
Zip code
030-8505
Address
58-1, Mase, Hamadate, Aomori City, Aomori, Japan
TEL
017-765-2100
n_yoshiike@auhw.ac.jp
Public contact
Name of contact person
| 1st name | Chinatsu |
| Middle name | |
| Last name | Hoka |
Organization
Aomori University of Health and Welfare
Division name
Graduate School of Health Science
Zip code
030-8505
Address
58-1, Mase, Hamadate, Aomori City, Aomori, Japan
TEL
017-757-8469
Homepage URL
https://womens-menses-lab.com/
2391007@auhw.ac.jp
Sponsor or person
Institute
Aomori University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Aomori Chuo Gakuin Univercity
IRB Contact (For public release)
Organization
Aomori University of Health and Welfare Institutional Review Board
Address
58-1, Mase, Hamadate, Aomori city, Aomori, Japan
Tel
017-765-2000
rinri2008@auhw.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
| 2024 | Year | 06 | Month | 10 | 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
| 2024 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062360
