| CTRI Number |
CTRI/2024/05/067670 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation and Usage Testing of a scale to check Birth Satisfaction |
|
Scientific Title of Study
|
Translation and cross-cultural Adaptation of Birth Satisfaction
Scale Revise (BSS-R) In Kannada Language |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smita Rajesh Prabhu |
| Designation |
MPT Student |
| Affiliation |
Manipal College Of Health Profession |
| Address |
Room No. 215,
Department of Physiotherapy
Second Floor
Manipal College Of Health Profession
Manipal Academy of Higher Education
Madhav Nagar
Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9869668079 |
| Fax |
|
| Email |
smita.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhamini Krishna Rao |
| Designation |
MPT,PHD, Professor |
| Affiliation |
Manipal College Of Health Profession |
| Address |
Department Of Physiotherapy,
Manipal College Of Health Profession, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8660644145 |
| Fax |
|
| Email |
bhamini.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha R |
| Designation |
PhD, ASSOCIATE Professor |
| Affiliation |
Manipal College Of Health Profession |
| Address |
Department Of Physiotherapy,
Manipal College Of Health Profession ,
Manipal Academy of Higher Education Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department Of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy Of Higher Education, Manipal,
Karnataka - 576104, India |
|
|
Primary Sponsor
|
| Name |
Manipal College Of Health Professions |
| Address |
Department Of Physiotherapy Manipal College Of Heath Professions
Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shripad Hebbar |
Department of obstetrics and Gynecology, Kasturba Hospital |
Ward no. WH2,WH4 and WH5, 3rd floor, Women and children block, Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
9611786463
shripad.hebbar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Age : 18 – 45 years old
2.Can able to understand Kannada
3.Delivered either through Cesarean section or normal delivery in Kasturba hospital |
|
| ExclusionCriteria |
| Details |
1)Women who had intrauterine death or neonatal death
2)Women who were diagnosed with psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Birth Satisfaction Scale Revise(BSS-R) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "124"
Final Enrollment numbers achieved (India)="124" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2024 |
| Date of Study Completion (India) |
17/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Need for the study : Lack of tools in Kannada version to identify the level of birth satisfaction BSS-R tool has not been translated and validated in the Kannada language
Purpose Of Study: Phase I : To translate using parallel back translation and to cross-cultural adapt into the Kannada language Phase II To pilot study and conduct factor analysis of BSS-R for understandability and ease of use in Kannada-speaking women
|