Understanding how women feel about their body during the last 3 months of their pregnancy.

Completed

• Conditions: Pregnancy related conditions, unspecified,

• Registration Number: CTRI/2023/08/056524
• Lead Sponsor: Ketaki Desai

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-28
• Last Update Posted: 2024-05-22
• Study Completion: 2024-10-02

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 246

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Image Perception using Multidimensional Body Self Image Questionnaire	Once

Trial Locations

Locations (1)

Kasturba Hospital, Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital, Manipal

🇮🇳Udupi, KARNATAKA, India

Dr Preetha R

Principal investigator

9945670669

preetha.r@manipal.edu