Clinical trial NCT05503680: The Effect of Yoga for Stress Among HIV Patients in Indonesia
Official title: The Effect of a Yoga Intervention for Reducing Stress Among People Living With HIV in Indonesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: yoga
Stress, Psychological
Human Immunodeficiency Virus
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: (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).
Secondary outcomes:
measure: The Brief Health status Survey
timeFrame: (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).
measure: 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.
timeFrame: (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).
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Jumpandang Baru Primary Health Care Center
state: South-Sulawesi
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Miao-Yen Chen, RN, PhD
role: STUDY_CHAIR
affiliation: National Taipei University of Nursing and Health Sciences
name: Jufri Hidayat, PhD (Cand)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chesney MA, Neilands TB, Chambers DB, Taylor JM, Folkman S. A validity and reliability study of the coping self-efficacy scale. Br J Health Psychol. 2006 Sep;11(Pt 3):421-37. doi: 10.1348/135910705X53155.
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.