| CTRI Number |
CTRI/2023/08/056524 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding how women feel about their body during the last 3 months of their pregnancy. |
|
Scientific Title of Study
|
Understanding body image perception of pregnant women in their third trimester |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ketaki Desai |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions,Manipal, Karnataka |
| Address |
Room no. 20, 2nd floor, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7338366113 |
| Fax |
|
| Email |
ketaki.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ketaki Desai |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 20, 2nd floor, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7338366113 |
| Fax |
|
| Email |
ketaki.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 211, 2nd floor, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
99945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Ketaki Desai |
| Address |
Manipal College of Health Professions, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preetha R |
Kasturba Hospital, Manipal |
Room number 12, Ground floor, OBG OPD, Women and Childrens block, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9945670669
preetha.r@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-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Phase I- Pregnant women between 18 to 40 weeks of gestation (Rest of the inclusion criteria and exclusion criteria same as Phase II)
Phase II- 1.Age: Pregnant women between 18-45 years
2. Period of gestation- 28 to 40 weeks of gestation
3. Those who can read either Kannada or English
|
|
| ExclusionCriteria |
| Details |
1. High-risk pregnancies (current or previous)
2. Single mothers (who lost their partner)
3. Conceived through Artificial Reproduction Therapy
4. Diagnosed psychiatric disorders
5. Any cardiorespiratory, neurological or musculoskeletal disorders which can affect their physical function
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Image Perception using Multidimensional Body Self Image Questionnaire |
Once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
Final Enrollment numbers achieved (Total)= "246"
Final Enrollment numbers achieved (India)="246" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2023 |
| Date of Study Completion (India) |
10/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Phase IA: Translation of MBSRQ Study approval from Institutional Research Committee (IRC), Manipal College of Health Professions, Manipal and Institutional Ethics Committee (IEC), Kasturba Hospital, Manipal will be obtained. The study will be registered in Clinical Trials Registry- India. After approval and registration :- - Forward translation of English version of MBSRQ to Kannada
- Parallel back translation of translated version
- Pre-final questionnaire development
Phase IB: Cultural- adaptation of the prefinal questionnaire among Kannada population The formulated version will be pre-tested by administering the questionnaire, collecting the versions after completion by participants and interviewing them to identify the level of understanding and emotional appropriateness of each question and reasoning of corresponding answer.
Phase II: Main study using MBSRQ The inclusion and exclusion criteria will be checked against potential participants. Participants’ written informed consent will be requested following comprehensive explanation. Body weight, height and waist circumference will be recorded and MBRSQ (English or Kannada as per the language known to the participant) will be administered to the participants between 28 to 40 weeks of gestation. The questionnaire will be given to the participants, and any questions about it can be addressed with the principal investigator. They will be asked to return the questionnaire after filling it. Data collected will be statistically analyzed. |