| CTRI Number |
CTRI/2024/12/078042 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Improving Caregivers Knowledge on Reproductive Health for Girls with Cerebral Palsy through Education Program in a Hospital Setting |
|
Scientific Title of Study
|
Effect of reproductive health education intervention for caregivers of girls with cerebral palsy in a tertiary care centre |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chithra Babu |
| Designation |
Primary Student Researcher |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no. 69, Department of Global Public Health Policy and Governance, Prasanna School of Public health, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
7498255247 |
| Fax |
|
| Email |
chithra.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arathi P Rao |
| Designation |
Head of Department |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no. 69, Department of Global Public Health Policy and Governance, Prasanna School of Public health, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arathi P Rao |
| Designation |
Head of Department |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no. 69, Department of Global Public Health Policy and Governance, Prasanna School of Public health, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Hospital - Kasturba Hospital Manipal- Department of pediatric orthopedic, cerebral palsy clinic. |
|
|
Primary Sponsor
|
| Name |
Dr Chithra Babu |
| Address |
Room No. 69, Department of Global Public Health Policy and Governance, Prasanna School of Public Health MAHE, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [self-sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arathi P Rao |
Prasanna School of Public Health |
Room no. 69, Department of Global Public Health Policy and Governance, Prasanna School of Public health, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA |
9008418848
arathi.anil@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -1 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational Intervention |
Educational intervention will be provided for a duration of 3 months.
This Educational Intervention is a 10–15-minute educational session after pretest. The educational session will be given by the PI, using predesigned IEC material, a print version of the same will be provided to each participant. After 3 months post test will be conducted. The IEC material (IEC booklet) has been validated in a prior PhD project with IEC no. 345/2015 and is now being tested.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Caregivers of Girls diagnosed with any level of cerebral palsy irrespective of attaining menarche.
2. Participants must be the caregivers (e.g., parents, guardians) responsible for their daily care and well-being of girls diagnosed with cerebral palsy.
3. Caregivers must provide informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caregivers Knowledge and practice related to reproductive health of girls with CP. |
3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2024 |
| Date of Study Completion (India) |
03/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The dissertation protocol, titled "Effect of reproductive health education intervention for caregivers of girls with cerebral palsy in a tertiary care centre," is an interventional-educational study designed to improve the knowledge and practices of caregivers regarding reproductive health. Girls with cerebral palsy (CP) face unique challenges related to growth, sexual development, and menstrual issues, which are often overlooked as caregivers prioritize orthopedic care. This study addresses these gaps by delivering an educational intervention using predesigned IEC (information,education,communication) material. The study involves - Pre-test, educational intervention, post-test.
1) Pretest - to assess baseline knowledge and practice with the help of a structured questionnaire.
2) Educational Intervention - a 10–15-minute educational session after pretest will be provided by the PI, using predesigned IEC material, a print version of the same will be provided to each participant. The IEC material has been validated in a prior PhD project with IEC no. 345/2015 and is now being tested.
3) Post test- a post-test three months later with the same questionnaire to evaluate the intervention’s effectiveness. Conducted over six months (January-June 2025) the study aims to enhance caregivers’ knowledge, practice and improve the quality of life for girls with CP. By generating evidence on the impact of reproductive health education, the research seeks to inform policy development, advocate for better reproductive health management, and establish best practices |