search
Back to results

The Effect of Yoga for Stress Among HIV Patients in Indonesia

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Yoga
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring yoga, Stress, Psychological, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jumpandang Baru Primary Health Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga group

Control group

Arm Description

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

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 Outcome Measures

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).
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 Outcome Measures

The Brief Health status Survey
This concept was measured by a tool the Brief Health status Survey that was commonly used by nurses and doctors at Jumpandang Baru medical center to assess patients who are visiting the clinic. This tool has been shortened for the purpose of this study. The items include: (1) self-reported rating of their health status (ranging from 1: very poor to 6: excellent); (2) blood pressure (mmHg); (3) height (cm) and weight (kg) will be combined for calculating BMI; (4) stress in the past month; (5) smoking; (6) alcohol and illicit drug use and the percentage with which they use it to cope with stress; (7) prescription medication and over the counter medications for coping with stress, and the percentage with which they use it to cope with stress. Validity test will be performed before data collection begin. The brief health status survey will be performed in three different time to see how the yoga intervention change the health status of participants before and after intervention.
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.
The concept of coping self-efficacy is measured by the 26-item Coping Self-Efficacy Scale (CSES) developed by Chesney et. al (2006). Participants respond using an 11-point rating scale - 0 to 10, with anchor points on the scale at 0, meaning, 'I cannot do it at all'; 5, meaning, 'I am moderately certain I can do it'; and 10, meaning 'I am certain I can do it. This scale has good reliability with Cronbach's alpha for factor one (use problem-focused coping) was 0.91, factor two (stop unpleasant thought) was 0.91 and factor three (get support from family and friends) was 0.80 (Chesney et al., 2006). The coping self-efficacy scale will be performed in three different time to see how the yoga intervention change the coping self-efficacy level of participants before and after intervention.

Full Information

First Posted
July 22, 2022
Last Updated
January 7, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05503680
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 18, 2022 (Actual)
Study Completion Date
December 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
yoga, Stress, Psychological, Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
In this study, we will blind the data collector
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Experimental
Arm Description
The experimental group is people living with HIV who will receive 120 minutes per week of yoga intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Other Intervention Name(s)
Hatha yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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.
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).
Secondary Outcome Measure Information:
Title
The Brief Health status Survey
Description
This concept was measured by a tool the Brief Health status Survey that was commonly used by nurses and doctors at Jumpandang Baru medical center to assess patients who are visiting the clinic. This tool has been shortened for the purpose of this study. The items include: (1) self-reported rating of their health status (ranging from 1: very poor to 6: excellent); (2) blood pressure (mmHg); (3) height (cm) and weight (kg) will be combined for calculating BMI; (4) stress in the past month; (5) smoking; (6) alcohol and illicit drug use and the percentage with which they use it to cope with stress; (7) prescription medication and over the counter medications for coping with stress, and the percentage with which they use it to cope with stress. Validity test will be performed before data collection begin. The brief health status survey will be performed in three different time to see how the yoga intervention change the health status of participants before and after intervention.
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).
Title
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.
Description
The concept of coping self-efficacy is measured by the 26-item Coping Self-Efficacy Scale (CSES) developed by Chesney et. al (2006). Participants respond using an 11-point rating scale - 0 to 10, with anchor points on the scale at 0, meaning, 'I cannot do it at all'; 5, meaning, 'I am moderately certain I can do it'; and 10, meaning 'I am certain I can do it. This scale has good reliability with Cronbach's alpha for factor one (use problem-focused coping) was 0.91, factor two (stop unpleasant thought) was 0.91 and factor three (get support from family and friends) was 0.80 (Chesney et al., 2006). The coping self-efficacy scale will be performed in three different time to see how the yoga intervention change the coping self-efficacy level of participants before and after intervention.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miao-Yen Chen, RN, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jufri Hidayat, PhD (Cand)
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jumpandang Baru Primary Health Care Center
City
Makassar
State/Province
South-Sulawesi
ZIP/Postal Code
90211
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be shared under permission and with reasonable reason.
Citations:
PubMed Identifier
16870053
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.
Results Reference
result
PubMed Identifier
6668417
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.
Results Reference
result

Learn more about this trial

The Effect of Yoga for Stress Among HIV Patients in Indonesia

We'll reach out to this number within 24 hrs