The Effect of Yoga for Stress Among HIV Patients in Indonesia

NCT05503680 | Completed DMC

• 1 other identifier: 2564/VII/SP/2022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

yoga; Stress, Psychological; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (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.

  (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)

• 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).

• 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).

Study Arms (2)

Yoga group

EXPERIMENTAL

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

Behavioral: Yoga

Control group

NO 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

Interventions

Yoga 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.

Also known as: Hatha yoga

Yoga group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Jumpandang Baru Primary Health Care Center

Makassar, South Sulawesi, 90211, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 16870053 RESULT

• 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.

  PMID: 6668417 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Stress, Psychological

Interventions

Yoga

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Miao-Yen Chen, RN, PhD

  National Taipei University of Nursing and Health Sciences

  STUDY CHAIR

• Jufri Hidayat, PhD (Cand)

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this study, we will blind the data collector
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 17, 2022
• Study Start: August 1, 2022
• Primary Completion: December 18, 2022
• Study Completion: December 18, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)