The Effect of a Yoga Intervention for Reducing Stress Among People Living With HIV in Indonesia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- 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).
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
In this study, we will blind the data collector
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Yoga group
The experimental group is people living with HIV who will receive 120 minutes per week of yoga intervention.
Intervention: Yoga (Behavioral)
Control group
In this study, the control group will receive standard care where participants usually receive various program from The local HIV clinic including general education program, health check-up, and oral antiretroviral regimen
Outcomes
Primary Outcomes
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).
Time Frame: (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.
Secondary Outcomes
- 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).)
Investigators
Jufri Hidayat
Principal investigator
National Taipei University of Nursing and Health Sciences