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Human Immunodeficiency VirusNCT05503680

The Effect of Yoga for Stress Among HIV Patients in Indonesia

A study testing Yoga in people with Human Immunodeficiency Virus, run by National Taipei University of Nursing and Health Sciences at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteIndonesia
Study dates
1 Aug 2022to 18 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Jumpandang Baru Primary Health Care Center

    Makassar, South Sulawesi, 90211

Other trials in Indonesia

About this study

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

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.

Read the 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.

Being tested
Yoga
Keywords
yoga, Stress, Psychological, Human Immunodeficiency Virus
Medical subject headings
Acquired Immunodeficiency Syndrome, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogaBehavioural

    Also called Hatha 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.

Study groups in NCT05503680
Study groupRoleWhat they receive
Yoga groupExperimentalThe experimental group is people living with HIV who will receive 120 minutes per week of yoga intervention.
Receives: Behavioral: Yoga
Control groupNo interventionIn 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: (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 (2)

  1. 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.

    Measured: (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).

  2. 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.

    Measured: (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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start1 Aug 2022
  3. Primary completion18 Dec 2022
  4. Study completion18 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05503680
Sponsor's protocol ID
2564/VII/SP/2022
Status last verified
Jan 2023
First submitted
22 Jul 2022
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will be shared under permission and with reasonable reason.

Publications

  • 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.

    PubMed 16870053

  • 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.

    PubMed 6668417

Questions about this trial

What is this clinical trial studying?

A study testing Yoga in people with Human Immunodeficiency Virus, run by National Taipei University of Nursing and Health Sciences at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). (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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05503680, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.

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