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Recruiting NCT07191288

Assessing the Acute Effects of Virtual Reality Interventions on Stress

No phase Interventional Slow Breathing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR (VR-Breathing+Mystical), VR (VR-Mystical), Computer (Non-VR-Breathing), VR (VR-Control).
Who it may be relevant to
Registry conditions: Slow Breathing. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Assessing the Acute Effects of Virtual Reality Interventions on Stress: A Four-Arm RCT

Overview

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.

Interventions

  • Device 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 slo
  • 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 th
  • 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.
  • Drug 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.

Primary outcome measures

  • Subjective stress [Time frame: Assessed before and after the 10-minute interventions.]
Secondary outcome measures (9)
  • Mood [Time frame: Assessed before and after the 10-minute interventions.]
  • Anxiety [Time frame: Assessed before and after the 10-minute interventions.]
  • Relaxation [Time frame: Assessed before and after the 10-minute interventions.]
  • Electrodermal Activity [Time frame: Assessed during the 10-minute interventions.]
  • Respiration [Time frame: Assessed during the 10-minute interventions.]
  • Blood volume pulse [Time frame: Assessed during the 10-minute interventions.]
  • Heart rate (variability) [Time frame: Assessed during the 10-minute interventions.]
  • Perceived mysticality [Time frame: Assessed after the 10-minute interventions.]
  • User experience [Time frame: Assessed after the 10-minute interventions.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University of Basel, Division of Cognitive Neuroscience — Basel

Identifiers

NCT: NCT07191288 · 2025-01814

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗