The Effect of Yoga for Stress Among HIV Patients in Indonesia

NCT ID: NCT05503680

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-12-18

Brief Summary

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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

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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.

Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

In this study, we will blind the data collector

Study Groups

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Yoga group

The experimental group is people living with HIV who will receive 120 minutes per week of yoga intervention.

Group Type EXPERIMENTAL

Yoga

Intervention Type BEHAVIORAL

In this study, the researcher will provide participants with two month of Hatha yoga as an experimental intervention for managing stress. All participants who belong to the intervention group will be required to complete 120 minutes per week of home-based, online streaming yoga for eight weeks with our certified yoga instructor. The intervention will be conducted online by Zoom video; participants will be sent a link to join a scheduled live online yoga session twice every week. The data collection will be undertaken in three times: baseline (before the intervention begins), posttest one ( after two month intervention), and posttest two (one month after yoga intervention finish) to evaluate the lasting effect of yoga.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yoga

In this study, the researcher will provide participants with two month of Hatha yoga as an experimental intervention for managing stress. All participants who belong to the intervention group will be required to complete 120 minutes per week of home-based, online streaming yoga for eight weeks with our certified yoga instructor. The intervention will be conducted online by Zoom video; participants will be sent a link to join a scheduled live online yoga session twice every week. The data collection will be undertaken in three times: baseline (before the intervention begins), posttest one ( after two month intervention), and posttest two (one month after yoga intervention finish) to evaluate the lasting effect of yoga.

Intervention Type BEHAVIORAL

Other Intervention Names

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Hatha yoga

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jufri Hidayat

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miao-Yen Chen, RN, PhD

Role: STUDY_CHAIR

National Taipei University of Nursing and Health Sciences

Jufri Hidayat, PhD (Cand)

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

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Jumpandang Baru Primary Health Care Center

Makassar, South Sulawesi, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type RESULT
PMID: 16870053 (View on PubMed)

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.

Reference Type RESULT
PMID: 6668417 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2564/VII/SP/2022

Identifier Type: -

Identifier Source: org_study_id

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