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Starting soon Not applicable

Virtual Reality to Reduce the Anxiety in Critically Ill Patient

NCT06747793 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-02
Last updated
2025-01-27

Condition(s) studied

AnxietyIntensive Care Unit Syndrome

Investigational drug(s) / intervention(s)

Virtual Reality

Virtual Reality: The intervention will consist of relaxing virtual reality stimulation, which will be started after obtaining informed consent. Immersive 360-degree videos (nature environments) will be played inside a head-mounted display, with the video sound played inside headphones. Each virtual reality video will last 30 minutes. The stimulation will be provided two times per day, morning and evening, every day until the patient ICU discharge, or the maximum of 7 days will be reached. The intervention group will also receive standard intensive care unit care, same as in the control group.

Study summary

Anxiety and discomfort generated by repeated medical cares and invasive procedures can induce cognitive disorders in critical illness survivors as post-traumatic stress disorder. For this reason, managing patients' anxiety is particularly important in the intensive care unit. Physicians have recently started using immersive virtual reality (VR), based on real-time interaction with an artificial 360° immersive world, as an adjunctive non-invasive and non-pharmacological anxiolysis technique. The purpose of this project is to assess the virtual reality stimulation to reduce anxiety in Intensive Care Unit (ICU) patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient * Oral consent after free and informed information * Hospitalized in the multipurpose intensive care unit of Rangueil hospital with an estimated length of stay greater than 24 hours * Conscious (Glasgow Coma Scale \> 8) and Richmond Agitation-Sedation Scale (RASS) sedation score between -1 and +1 * Mechanically ventilated or not * Person affiliated to or beneficiary of a social security system. Exclusion Criteria: * Patient under legal protection (guardianship or curatorship) * RASS \< -1 or \> +1 * Visual or hearing difficulties preventing the use of the VR headset * Severe psychiatric history (severe depression, psychosis, bipolarity), advanced dementia or mental retardation * Hemodynamic (Norepinephrine support \> 0.5 gamma/kg/min) and/or respiratory instability (invasive mechanical ventilation with FiO2 greater than 80%) * Presence of a malformation or cervical or facial trauma that does not allow the application of the VR headset * Pregnancy or breastfeeding

Primary outcome measure(s)

  • Patients' anxiety level after using virtual reality — 7 days
    Visual Analogue Scale for Anxiety (VAS-A) is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Toulouse Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06747793 on ClinicalTrials.gov ↗ ← All trials in France