Assessing the Acute Effects of Virtual Reality Interventions on Stress

NCT ID: NCT07191288

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR-Breathing+Mystical

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

Group Type: EXPERIMENTAL

VR (VR-Breathing+Mystical)

Intervention Type: 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-Mystical

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).

Group Type: EXPERIMENTAL

VR (VR-Mystical)

Intervention Type: 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.

Non-VR-Breathing

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

Group Type: EXPERIMENTAL

Computer (Non-VR-Breathing)

Intervention Type: 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.

VR-Control

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

Group Type: SHAM_COMPARATOR

VR (VR-Control)

Intervention Type: 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.

Interventions

VR (VR-Breathing+Mystical)

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.

Intervention Type: DEVICE

VR (VR-Mystical)

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.

Intervention Type: DEVICE

Computer (Non-VR-Breathing)

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.

Intervention Type: DEVICE

VR (VR-Control)

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dominique de Quervain, MD

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dominique de Quervain, MD

Director Division Cognitive Neuroscience

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominique de Quervain, Prof. MD

Role: STUDY_CHAIR

University of Basel, Research Platform Molecular and Cognitive Neuroscience

Locations

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Central Contacts

Fabian Mueller, Msc

Role: CONTACT

fabi.mueller@unibas.ch

+41612070272

Facility Contacts

Dominique de Quervain, Prof. MD

Role: primary

dominique.dequervain@unibas.ch

+41 61 207 02 37

Other Identifiers

2025-01814

Identifier Type: -

Identifier Source: org_study_id