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临床试验/CTRI/2024/04/066110
CTRI/2024/04/066110已完成不适用

The effect of Mindful Breathing and Positive Affirmations on women with Polycystic Ovarian Syndrome: An Intervention Module

Yukti1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月3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
100
试验地点
1
主要终点
Body image scale scores and quality of life brief scores

研究概览

简要总结

A total of 100 women with PCOS along with poor quality of life and higher levels of body image concerns between the age range of 20-45 years will be screened for the study. The women who do not meet the criteria or decline to participate will be excluded. Further, the pre-assessment will be done. The assessed individuals will be then categorized into two groups, first the experimental group and the control group. Consequently, a total of 50 PCOS patients will be allocated to the experimental group and 50 to the control group. The experimental group will receive the intervention (mindful breathing technique and positive affirmations) for 6 weeks consisting of weekly meetings (twice a week). In the initial sessions, education about the intervention program will be given followed by mindful breathing and the use of positive affirmations. Each session will be of half an hour. The individuals will be instructed to practice mindful breathing in the morning for 15 mins daily and practice positive affirmations 3-4 times a day. They will also be asked to maintain a journal to keep the record. Participants will be reminded on a regular basis through telephone to continue the practice. After a duration of 6 weeks, they will be reassessed to see the effect of the interventions, and then a follow-up will be taken.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Women clinically diagnosed with Polycystic ovary disorder (PCOS) for at least 1 year 2) Age range: 20-45 years 3)Literate women 4) Both married and unmarried women with Indian nationality.

排除标准

  • Women with a history of severe psychiatric disorder 2) Pregnant women 3) Women living outside Delhi NCR.

结局指标

主要结局

Body image scale scores and quality of life brief scores

时间窗: 1 year

次要结局

  • overall satisfaction with life(satisfaction with body)

研究者

发起方
Yukti
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Yukti

SGT University

研究点 (1)

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