UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050490 |
|---|---|
| Receipt number | R000057514 |
| Scientific Title | Effects of Involvement of Male Counterparts in Menstrual Hygiene Management of Women and Adolescent Girls with Disabilities in Selected Sub-districts of Bangladesh: A Quasi-Experimental Study |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2024/09/27 22:26:49 |
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Basic information
Public title
Effects of Involvement of Male Counterparts in Menstrual Hygiene Management of Women and Adolescent Girls with Disabilities in Selected Sub-districts of Bangladesh: A Quasi-Experimental Study
Acronym
Menstrual Hygiene Management, Disability, Male Counterparts, Involving Male Counterparts, Women and Adolescent Girls with Disabilities
Scientific Title
Effects of Involvement of Male Counterparts in Menstrual Hygiene Management of Women and Adolescent Girls with Disabilities in Selected Sub-districts of Bangladesh: A Quasi-Experimental Study
Scientific Title:Acronym
Menstrual Hygiene Management, Disability, Male Counterparts, Involving Male Counterparts, Women and Adolescent Girls with Disabilities
Region
| Asia(except Japan) |
Condition
Condition
Women and adolescent girls with disabilities
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if the menstrual hygiene management of women and adolescent with disabilities can be improved by the intervention involving their male counterparts (father, husband, elder brother) in selected sub-districts of Bangladesh.
Basic objectives2
Others
Basic objectives -Others
To assess the current menstrual hygiene management practices among women and adolescent girls with disabilities in selected sub-districts of Bangladesh.
To determine the level of involvement of male counterparts in menstrual hygiene management among women and adolescent girls with disabilities in selected sub-districts of Bangladesh.
To investigate the impact of involving male counterparts in menstrual hygiene management on the menstrual hygiene practices of women and adolescent girls with disabilities in selected sub-districts of Bangladesh.
To identify the challenges and opportunities for involving male counterparts in menstrual hygiene management of women and adolescent girls with disabilities in selected sub-districts of Bangladesh.
To develop recommendations for policymakers, stakeholders, and practitioners to improve the menstrual hygiene management of women and adolescent girls with disabilities in Bangladesh, with a focus on the involvement of male counterparts.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of menstrual hygiene management of women and adolescent girls with disabilities in selected sub-districts of Bangladesh.
Key secondary outcomes
1)Improvement of menstrual physiology and hygiene management knowledge among study participants.
2)Improvement of supply chain of menstrual materials, WASH facilities and disposal mechanism.
3)Improvement of social support for women and adolescent girls with disabilities by involving male counterparts.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group will receive ten months health education on menstrual health and hygiene management, role of male counterparts in menstrual health and hygiene management.
Interventions/Control_2
The control group will receive ten months of health education on family planning.
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
| 10 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for girls with disability:
Age limit: 10 - <18 years age
Disability status: Physical, hearing, visual disability and combined
Duration of stay in the study site: More than or equal six months
Inclusion criteria for women with disability:
Age limit: 18 - 45 years
Disability status: Physical, hearing, visual disability and combined
Duration of stay in the study site: More than or equal six months
Inclusion criteria for male counterpart:
Relationship status with the female participant: Husband/father/elder brother
Age limit: 18-65 years
Duration of stay in the study site: More than or equal six months
Key exclusion criteria
Women and adolescent girls with mental and intellectual disabilities
Women and adolescent girls with terminal illness
Not willing to participant of the study (male or female counterpart)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Munzur |
| Middle name | E |
| Last name | Murshid |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
7348551
Address
1-2-3 Kasumi, Minami Ward, Hiroshima
TEL
+81-070-8968-0941
d221843@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Munzur |
| Middle name | E |
| Last name | Murshid |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
7348551
Address
1-2-3 Kasumi, Minami Ward, Hiroshima
TEL
+81-070-8968-0941
Homepage URL
d221843@hiroshima-u.ac.jp
Sponsor or person
Institute
Self
Institute
Department
Personal name
Funding Source
Organization
Kakenhi Grants in Aid for Scientific Research Activity Start up (Project Number - 23K19805)
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-23K19805/
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
National Institute of Preventive and Social Medicine
Address
Mohakhali, Dhaka, Bangladesh - 1212
Tel
+88-02-9842275
nipsom@ld.dghs.gov.bd
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
| 2023 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
152
Results
DOI: 10.7759/cureus.47704
DOI: 10.7759/cureus.49605
DOI: 10.7759/cureus.54953
DOI: 10.7759/cureus.68009
Results date posted
| 2023 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Significant unmet menstrual practice needs identified in both group (intervention and control) of the study.
Participant flow
Total 152 participants recruited considering 30% lost to follow up
Adverse events
N/A
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057514
