跳至主要内容
临床试验/NCT05503680
NCT05503680已完成不适用

The Effect of a Yoga Intervention for Reducing Stress Among People Living With HIV in Indonesia: A Randomized Controlled Trial

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Perceived stress scale (this study will measure the the phenomenon of stress among PLWH using the Perceived Stress Scale developed by Dr. Sheldon Cohen in 1983).

研究概览

简要总结

This study is aimed to evaluate the effects of yoga intervention versus usual care (control group) for reducing stress among people living with HIV in Indonesia.

详细描述

Introduction

Human immunodeficiency virus (HIV) continues to be a public health challenge for four decades after the disease appeared. Stress is one of the most common mental health problems that occur among people living with HIV. Yoga is increasingly popular as one of the complementary therapies in health care systems including in nursing. Moreover, much evidence shows that yoga is a promising modality to be used to treat stress and to maintain the health and wellbeing of PLWH.

Purpose: The primary objective in this study is to evaluate the effects of yoga intervention versus usual care (control group) for reducing stress among people living with HIV in Indonesia.

Methods: This study will use a parallel group randomized controlled trial (RCT) design, with single blinding, and repeated measures. Sample will be divided into a yoga intervention group and a routine care group as the control group. In this study, the independent variable is defined as yoga intervention, and the dependent variable is stress. In total, participants who will participate is sixty-six, thirty-three participants in yoga group and thirty-three in control group. The Generalized Estimating Equation will be performed for the data analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

In this study, we will blind the data collector

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants are patients who
  • Had been diagnosed with HIV.
  • Were newly diagnosed or had taken ARV medication for at least one month.
  • Are age 18 years or older.
  • Have access to a desktop, laptop, or smartphone on a regular basis.
  • Have access to reliable internet.
  • Are fluent in Indonesian.
  • Are willing to participate and sign the consent form.
  • Are willing to be blood tested for CD4 counts or viral load at baseline and eight weeks after the intervention.

排除标准

  • Patients who did not qualify to participate were:
  • Those who reported performing yoga or other body-mind exercises at least one-month prior to the start of this study.
  • Those who were not in physically fit condition
  • Those who had been diagnosed with musculoskeletal problems, i.e., osteoporosis, osteoarthritis, bone injury, or spine problems.
  • Those who have difficulty keeping their balance.
  • Those who are currently pregnant, or plan to become pregnant during the trial.

结局指标

主要结局

Perceived stress scale (this study will measure the the phenomenon of stress among PLWH using the Perceived Stress Scale developed by Dr. Sheldon Cohen in 1983).

时间窗: (1) Pre-test (before yoga intervention), (2) Post-test one / at the week-eight (after yoga intervention finish), (3) Post-test two for following up (at the week twelve or one month after yoga intervention finish).

The scale uses a 5-point rating scale from never (0) to very often (4) to measure the degree to which a person judges situations in their life to be stressful. This scale contains 10 items. Scores range from 1 to 40, with higher scores reflecting greater perceived stress. This scale has sufficient internal consistency with Cronbach alpha 0.78 (Cohen et al., 1983). The stress will be measured in three different time to see how the yoga intervention change the level of stress of participants, before and after intervention.

次要结局

  • Coping Self-Efficacy Scale (The definition of coping self-efficacy is defined based on the concept proposed by Chesney et al in 2006 where they defined coping self-efficacy refers to the capacity to cope effectively with life obstacles.((1) Pre-test (before yoga intervention), (2) Post-test one / at the week-eight (after yoga intervention finish), (3) Post-test two for following up (at the week twelve or one month after yoga intervention finish).)
  • The Brief Health status Survey((1) Pre-test (before yoga intervention), (2) Post-test one / at the week-eight (after yoga intervention finish), (3) Post-test two for following up (at the week twelve or one month after yoga intervention finish).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jufri Hidayat

Principal investigator

National Taipei University of Nursing and Health Sciences

研究点 (2)

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