跳至主要内容
临床试验/CTRI/2021/07/035274
CTRI/2021/07/035274尚未招募不适用

Development and evaluation of a yoga-based intervention program to deal with the psychological distress among family members of the healthcare workers engaged in the management of COVID-19 patients

DST Satyam1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Improvement in mental well being as measured by DASS scores

研究概览

简要总结

Background: The outbreak of the novel coronavirus, COVID-19, has been declared a Public Health Emergency. It has caused serious psychological distress stress, anxiety and depression in the general population, especially amongst asymptomatic and affected patients, healthcare workers, caregivers and family members. Amongst these, family members of healthcare workers is an important section of the society which might get overlooked. There is no treatment protocol to manage stress in this section during COVID pandemic. Yoga as an adjunct therapy with standard care has been useful in managing psychological distress in the general population.

Also, there is no evidence on the effect of yoga on management of stress among family members of healthcare workers.

Rationale: The outbreak of COVID 19 has led to unprecedented strict quarantine measures to contain the virus in India, which is proving to be a threat to psychological wellbeing of the general population. Amongst these, family members of healthcare workers will be the worst affected. Moreover, temporary isolation faced by family members from healthcare staff might enhance their distress. These groups require effective counselling techniques to reduce psychological distress. Yoga is known to be an effective intervention in managing psychological distress. There is a lack of an integrated yoga based intervention module to deal with psychological distress amongst this section, which is simple, effective and can be easily instructed through the internet and practiced at home. Besides, quarantine and isolation in current time warrants development of a noble way of learning and practising yoga which is effective yet practical.

Hypothesis

We hypothesize that yoga-based intervention will be more effective in overcoming psychological distress during the time of pandemic family members of the healthcare workers engaged in the management of COVID 19 patients.

Primary objective

To study the effectiveness of yoga-based intervention in reducing the psychological distress among family members of healthcare workers engaged in management of COVID 19 patients.

Secondary objective

  1. To develop a yoga-based intervention to manage psychological distress in family members of healthcare workers engaged in management of COVID 19 patients.

Methodology: The aim of this study is to develop and evaluate the efficacy of yoga based intervention programs to manage psychological distress stress, depression and anxiety in family members of healthcare workers. The study will be conducted in three phases. Phase I will involve development of a yoga based intervention module by extensive literature review and focus group discussion with the experts. In phase II, 364 family members will be screened using Depression Anxiety Stress Scale DASS to be enrolled in the third phase of the study. Phase III is a randomised controlled trial RCT to assess the effectiveness of the devised yoga based intervention. In this RCT, we intend to recruit 54 family members. Twenty seven family members will receive yogic intervention with standard care and 27 family members will receive only standard care. The change in DASS scores will be studied post intervention as outcome measures.

Proposed Outcome The study will provide a yoga module which can be used to cope with distress among family members. The family members practicing this intervention will have improvement in physical and mental wellbeing and will become an effective support system for healthcare workers engaged in the management of COVID 19 patients.

This module can be further developed to be implemented in family members of patients suffering from chronic disease.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Family members of the healthcare workers Intend to follow up regularly will be included in the study Individuals should be able to comprehend the instructions of a structured scale Individuals who are able to read and write.

排除标准

  • •Patients with Known psychiatric illnesses Patients with significant psychiatric comorbidity warranting hospitalization.

结局指标

主要结局

Improvement in mental well being as measured by DASS scores

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
DST Satyam
申办方类型
Government funding agency

研究点 (1)

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