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临床试验/CTRI/2023/08/056524
CTRI/2023/08/056524已完成不适用

Understanding body image perception of pregnant women in their third trimester

Ketaki Desai1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2023年8月28日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
246
试验地点
1
主要终点
Body Image Perception using Multidimensional Body Self Image Questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 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
  • Period of gestation- 28 to 40 weeks of gestation
  • Those who can read either Kannada or English.

排除标准

  • High-risk pregnancies (current or previous)
  • Single mothers (who lost their partner)
  • Conceived through Artificial Reproduction Therapy
  • Diagnosed psychiatric disorders
  • Any cardiorespiratory, neurological or musculoskeletal disorders which can affect their physical function.

结局指标

主要结局

Body Image Perception using Multidimensional Body Self Image Questionnaire

时间窗: Once

次要结局

未报告次要终点

研究者

发起方
Ketaki Desai
申办方类型
Other [self]

研究点 (1)

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