Assessing the Acute Effects of Virtual Reality Interventions on Stress

NCT07191288 | Recruiting

• 1 other identifier: 2025-01814
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A Four-Arm RCT, testing the acute effects of a Virtual Reality (VR)- based slow-paced breathing intervention on subjective and physiological markers of stress. The investigator hypothesize that combining slow breathing with immersive, mystical-type VR elements will result in the greatest stress reduction.

Conditions

Slow Breathing

Keywords

Virtual Reality; Stress; Breathing; Biofeedback

Outcome Measures

Primary Outcomes (1)

• Subjective stress

  Subjective stress measured using visual analogue scales (VAS) on a computer

  Assessed before and after the 10-minute interventions.

Secondary Outcomes (9)

• Mood

  Assessed before and after the 10-minute interventions.

• Anxiety

  Assessed before and after the 10-minute interventions.

• Relaxation

  Assessed before and after the 10-minute interventions.

• Electrodermal Activity

  Assessed during the 10-minute interventions.

• Respiration

  Assessed during the 10-minute interventions.

Study Arms (4)

VR-Breathing+Mystical

EXPERIMENTAL

Participants engage in guided slow-paced breathing using VR that provides mystical-type visual feedback.

Device: VR (VR-Breathing+Mystical)

VR-Mystical

EXPERIMENTAL

Participants passively view the same nature scene as in the first condition (VR-Breathing+Mystical), but without guided breathing instructions (i.e., they breathe naturally).

Device: VR (VR-Mystical)

Non-VR-Breathing

EXPERIMENTAL

Participants follow a slow-paced breathing pattern guided by a simple visual cue (expanding/contracting circle) on a standard computer screen.

Device: Computer (Non-VR-Breathing)

VR-Control

SHAM COMPARATOR

To control for the effects of experiencing VR, participants will watch a neutral documentary in a video player implemented in VR.

Drug: VR (VR-Control)

Interventions

VR (VR-Mystical) DEVICE

Users will experience the gradual unveiling of a beautiful natural landscape as the fog lifts, and eventually, the scene slows down similar to the VR Breathing+Mystical condition. However, this application does not provide any biofeedback or breathing instructions. Users are invited to passively observe the unfolding experience, immersing themselves in the environment for 10 minutes. Relaxing music accompanies the scene. This condition relies solely on the immersive and aesthetic qualities of the virtual environment to potentially induce relaxation.

VR-Mystical

Computer (Non-VR-Breathing) DEVICE

In this conventional breathing intervention, participants will be instructed to follow a slow-paced breathing pattern guided by a simple visual cue (an expanding and contracting circle) displayed on a computer screen for 10 minutes. This condition is designed to guide slow-paced breathing without incorporating any rewarding elements.

Non-VR-Breathing

VR (VR-Control) DRUG

In the control condition, participants will watch a neutral documentary for 10 minutes in VR. This condition is used to control for the effects of the immersive VR experience. It does not include any components related to guided breathing or mystical-type content, or any form of rewarding elements.

VR-Control

VR (VR-Breathing+Mystical) DEVICE

The VR-based slow-paced breathing application is designed to provide rewarding biofeedback for a specific breathing pattern characterized by prolonged exhales. As users extend their exhales, a veil of fog gradually lifts, introducing a mystical type experience. Over time, users are rewarded with a full 360-degree panoramic view of the beautiful nature scene, accompanied by relaxing music. After approximately 5 minutes of prolonged exhales, the nature scene responds to the user's breathing by slowing down, with falling snowflakes moving more slowly, further enhancing the mystical atmosphere. This intervention was designed to be visually captivating, mystically evocative, and emotionally engaging. Duration: 10 minutes.

VR-Breathing+Mystical

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \> 60 points on the PSQ-30 out of a maximum 120-point scale in the screening
• Healthy
• Aged between 18-35
• Fluent in German

You may not qualify if:

• A current diagnosis of psychiatric disorders (self-reported)
• Chronic medication use (except oral contraceptives)
• Parallel participation in another medical or psychological study
• Suicidal tendencies (PHQ-9 item 9 \> 0)3
• PHQ-9 score ≥ 10
• A visual impairment not corrected by glasses or contact lenses

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, 4055, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypoventilation; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Dominique de Quervain, Prof. MD

  University of Basel, Research Platform Molecular and Cognitive Neuroscience

  STUDY CHAIR

Central Study Contacts

Fabian Mueller, Msc

CONTACT

+41612070272; fabi.mueller@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Division Cognitive Neuroscience

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: March 5, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available after publication, study protocol (including statistical analysis plan) will be made available before start of the study.
• Access Criteria: All IPD (de-identified) that underline results in a publication will be shared upon reasonable request for scientific purposes. A reasonable request consists of a short description of the scientific purpose. Request will be reviewed by the team of the principal investigator.

Locations

CH (1)