UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051987 |
|---|---|
| Receipt number | R000059288 |
| Scientific Title | Development of E-Learning Materials to Promote Health Behaviors for Menstrual Pain in Female University Students: A Before-After Trial |
| Date of disclosure of the study information | 2023/08/24 |
| Last modified on | 2024/03/02 23:58:04 |
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Basic information
Public title
Development of E-Learning Materials to Promote Health Behaviors for Menstrual Pain in Female University Students
Acronym
Development of E-Learning Materials for Menstrual Pain
Scientific Title
Development of E-Learning Materials to Promote Health Behaviors for Menstrual Pain in Female University Students: A Before-After Trial
Scientific Title:Acronym
Development of E-Learning Materials for Menstrual Pain
Region
| Japan |
Condition
Condition
Menstrual pain
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop e-learning materials for promoting health behaviors among female university students for menstrual pain that disturbs their daily life
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The stages of behavior change during gynecological consultation immediately after the intervention
Key secondary outcomes
･The stages of behavior change in effective analgesic use for menstrual pain immediately after the intervention
･The stages of behavior change in self-monitoring of menstrual pain immediately after the intervention
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
One viewing of the e-learning material for a duration of 30 min
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Students who feel that menstrual pain is a disturbance in daily life
Key exclusion criteria
･Students receiving treatments at the gynecology clinic
･Students with a history of endometriosis, uterine leiomyoma, adenomyosis, ovarian cyst, and/or secondary dysmenorrhea
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
Self-funding
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
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
聖徳大学（千葉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 24 | 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
55
Results
The analysis included 38 participants. Seeking gynecological consultation (<.001) and self-monitoring of menstrual pain (<.001) significantly progressed regarding the stages of behavior change. Thus, the developed e-learning material may advance the stages of behavior change concerning menstrual pain.
Results date posted
| 2024 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants' mean age was 19.7 years (SD=1.19) and 55.3% had a dysmenorrhea score of >= 3, which is a criterion for recommending consultation.
Participant flow
Eligible participants: 48
Consented participants: 48
Intervention participants: 38
Analysis participants: 38
Adverse events
None
Outcome measures
Primary outcomes
The stages of behavior change during gynecological consultation significantly progressed after exposure to the material (<.001).
Secondary outcomes
The stages of behavior change seeking self-monitoring of menstrual pain significantly progressed after exposure to the material (<.001).
The stages of behavior change seeking effective use of analgesics had no significant difference before and after exposure to the material (.375).
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059288
