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临床试验/NCT07191288
NCT07191288招募中不适用

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

Prof. Dominique de Quervain, MD1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年3月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Subjective stress

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

VR-Breathing+Mystical

Experimental

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

干预措施: VR (VR-Breathing+Mystical) (Device)

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).

干预措施: VR (VR-Mystical) (Device)

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.

干预措施: Computer (Non-VR-Breathing) (Device)

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.

干预措施: VR (VR-Control) (Drug)

结局指标

主要结局

Subjective stress

时间窗: Assessed before and after the 10-minute interventions.

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

次要结局

  • Blood volume pulse(Assessed during the 10-minute interventions.)
  • 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.)
  • Heart rate (variability)(Assessed during the 10-minute interventions.)
  • Perceived mysticality(Assessed after the 10-minute interventions.)
  • User experience(Assessed after the 10-minute interventions.)

研究者

发起方
Prof. Dominique de Quervain, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dominique de Quervain, MD

Director Division Cognitive Neuroscience

University of Basel

研究点 (1)

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