| CTRI Number |
CTRI/2022/10/046703 [Registered on: 21/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Menstruation management of adolescents with Intellectual Disability |
|
Scientific Title of Study
|
Menstruation management of adolescents with Intellectual Disability in Udupi town: A cross-sectional survey |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchi Rajeev Bal |
| Designation |
Student researcher studying Masters of Occupational Therapy in Developmental Disabilities |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
8691025786 |
| Fax |
|
| Email |
ruraba1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Banumathe K R |
| Designation |
Associate professor and Guide |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy Manipal College of Health Professions MAHE Manipal Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
9035120310 |
| Fax |
|
| Email |
banumathe.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Rajeev Bal |
| Designation |
Student researcher studying Masters of Occupational Therapy in Developmental Disabilities |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India.
KARNATAKA
576104
India |
| Phone |
8691025786 |
| Fax |
|
| Email |
ruraba1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Asare Special Children Home School Rehabilitation Centre - Infrastructural support |
| Asha Nilaya School and Vocational Rehabilitation Centre for Mentally Challenged- Infrastructural support |
| Chethana Special School-Infrastructural support |
| Manasa Rehabilitation and Training Centre- Infrastructural support |
| Self- monetary support |
|
|
Primary Sponsor
|
| Name |
Ruchi Rajeev Bal |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India. |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Jayvittal |
Asare Special Children Home School Rehabilitation Centre |
Opposite KMC Quarters,
B-238 Madhav Nagar,
Manipal, Karnataka 576104
Udupi
KARNATAKA |
9742503805
archanatrust@gmail.com |
| Jayavijaya Kumari |
Asha Nilaya School and Vocational Rehabilitation Centre for Mentally Challenged |
Near Lombard Memorial Hospital Shanthinagar Udupi 576101 KARNATAKA
Udupi
KARNATAKA |
9886280335
ashaschool1981@gmail.com |
| Raghunath Shetty |
Chethana Special School |
Bharathi Seva Mandal trust Behind Sri Krishna Kshethra, Anekere, Karkala
Udupi
KARNATAKA |
9448725305
chethanaspecialschool@yahoo.in |
| Sr Ancilla Fernandes |
Manasa Rehabilitation and Training Centre |
Post Padubelle Via Shirva Pamboor 574116
Udupi
KARNATAKA |
8277219524
manasa_pamboor@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 (Student Research) |
Approved |
| No objection certificate from schools |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents/Caregivers of Adolescents with ID who is managing their children’s menstruation for at least a minimum of one year. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Parents/Caregivers of Adolescents with ID who is managing their children’s menstruation for atleast minimum of one year.
Parents/Caregivers of adolescents with ID who can comprehend either English or Kannada.
|
|
| ExclusionCriteria |
| Details |
Parents/Caregivers with known physical impairments or psychiatric illnesses. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Menstrual Management Questionnaire for Parents/Caretakers(MMQ-P/C) |
The study is a one time cross sectional survey |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/10/2022 |
| Date of Study Completion (India) |
06/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: The aim of the study is to determine the menstruation management of adolescents with ID in Udupi town.Justification: Menstruation can be particularly difficult for adolescents with ID because they have difficulty learning and applying new skills, causing caregivers to have additional responsibilities. Parents or caregivers lack information or guidance in preparing adolescents with ID for menstruation or caring for themselves. There is a dearth of literature available in a context pertaining to this. Therefore, a study on understanding menstruation management in adolescents with ID is needed. |