NCT07310017

Brief Summary

The present study aims to investigate the combined and comparative effects of yoga exercise performed with and without virtual reality (VR) support on stress levels, core stabilization, and balance in university students aged 18-30. Participants will be screened using validated stress assessment tools to ensure inclusion of individuals with moderate to high perceived stress. Eligible participants will then be randomly assigned to one of two groups:(1) a virtual reality yoga group (VRYG), in which yoga sessions are delivered through immersive VR environments with therapist-guided breathing and movement instruction; and (2) a Traditional Yoga Group (TYG), in which the same therapist will give the same breathing and movement instructions without VR. Both groups will undergo 12 supervised sessions over a period of four weeks (three sessions per week, each lasting 30 minutes). The intervention protocol includes a structured series of yoga postures designed to target trunk stability, flexibility, and balance, along with breathing techniques such as diaphragmatic breathing and the 4-7-8 method to promote relaxation and stress reduction. The VR group will perform these exercise within calming, immersive virtual environments,while the control group will perform them in a quite,well-lit physical space. Outcome measures will be collected at baseline and after completion of the intervention. Psychological stress will be evaluated using the Depression, anxiety, and stress scale (DASS-21) with a focus on the stress sub-scale.Physiological indicators, including heart rate and blood pressure will be recorded at rest. Core stabilization will be assessed through plank and side-plank endurance tests, while balance will be evaluated using both static (single-leg stance) and dynamic (Y-Balance Test) protocols. These measures will allow for a comprehensive analysis of the intervention's effects on both mental and physical domains of health.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

November 26, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

Mind-body interventionImmersive therapyBreathing exerciseRelaxation

Outcome Measures

Primary Outcomes (3)

  • Stress level Balance performance(Y-balanced test)

    Stress will be measured by the Depression, Anxiety, and Stress Scale (DASS-21) - Stress Subscale The DASS-21 Stress Subscale evaluates the participants' perceived stress levels over the past week. It consists of seven items rated on a 4-point scale ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). The stress subscale focuses on symptoms such as difficulty relaxing, nervous tension, irritability, and feeling easily upset. Total scores are calculated by summing the item scores and multiplying by two to obtain a standardized value. Higher scores indicate greater stress levels. This assessment was used to determine the changes in stress levels before and after the intervention.

    Through study completion, an average of 1 month

  • Heart rate

    Heart rate (beats per minute/bpm) will be measured to assess the physiological stress response. Measurements will be taken using a digital heart rate monitor while participants are seated comfortably. Each participant rested for five minutes prior to the measurement to ensure accuracy. The heart rate will be recorded three times at one-minute intervals, and the average of the three readings will be used for analysis. A decrease in post-intervention heart rate indicates improved relaxation and reduced physiological stress.

    Through study completion, an average of 1 month

  • Blood pressure

    Systolic and Diastolic blood pressure (in mmHg) will be assessed to evaluate cardiovascular responses associated with stress and relaxation. Measurements will be taken using an automatic digital sphygmomanometer on the participant's dominant arm while seated. Participants rested for at least five minutes before the first reading. Three consecutive readings will be obtained, and the average of the systolic and diastolic values will be calculated for analysis. Lower post-intervention readings reflect improved cardiovascular regulation and reduced stress levels.

    Through study completion, an average of 1 month

Secondary Outcomes (4)

  • Core Stabilization-Plank

    Through study completion, an average of 1 month

  • Core Stabilization-Side Plank

    Through study completion, an average of 1 month

  • Static balance

    Through study completion, an average of 1 month

  • Dynamic balance

    Through study completion, an average of 1 month

Study Arms (2)

Virtual Reality Yoga Group

EXPERIMENTAL
Other: YogaOther: Virtual Reality

Traditional Yoga Group

ACTIVE COMPARATOR
Other: Yoga

Interventions

YogaOTHER

A structured yoga program designed to improve core stability, postura balance, and stress management. The traditional yoga sessions will focus on breathing control, static and dynamic postures, and progressive muscles engagements. Each session last 30 minutes it's supervised by a physiotherapist, and takes place in a quiet room to minimise external distractions.

Traditional Yoga GroupVirtual Reality Yoga Group

The VR environment will be created by the MetaQuest 2 which is a immersive virtual realty headset. During the application, the environment will be chosen by the participants among pre-decided virtual environments, such as forest or ocean. According to the environment, the objects around the participants will move with their sounds. The sounds will be only related to the environment like the bird sound, waterfall sound or the wave sound. There is no instruction in the environment.

Virtual Reality Yoga Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • University student aged 18-30
  • Moderate-to-high perceived stress levels (DASS-21)
  • No contraindications for yoga or VR use

You may not qualify if:

  • Diagnosed psychological conditions requiring treatment
  • Musculoskeletal limitations that prevent participation
  • Use of medications affecting stress
  • Current participation in structured stress-reduction programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fizyoterapi ve Rehabilitasyon Uygulama ve Araștırma Merkezi (İSÜFİZYOTEM)

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Health Behavior

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Dr. Öğr. Üyesi Çiçek Günday, Asst. Prof.

    Istinye University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Öğr. Üyesi Çiçek Günday, Asst. Prof

CONTACT

PT Lamia Nidal Naeem Matran, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 30, 2025

Study Start

June 19, 2025

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations