Virtual Reality to Reduce the Anxiety in Critically Ill Patient

NCT06747793 | Not Yet Recruiting

• 1 other identifier: RC31/23/0617
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Intensive Care Unit Syndrome

Keywords

Intensive care unit; virtual reality; anxiety; depression; sleep quality

Outcome Measures

Primary Outcomes (1)

• Patients' anxiety level after using virtual reality

  Visual Analogue Scale for Anxiety (VAS-A) is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety

  7 days

Secondary Outcomes (6)

• Difference in patient anxiety after using virtual reality

  between inclusion and the day 7

• Evolution of the psychopathological status: depression

  3 months

• Evolution of the psychopathological status: anxiety

  3 months

• Evolution of the Sleep quality

  every day through study completion, an average of 5 days

• Evaluation of the Safety of using vitural reality in intensive care unit

  every day through study completion, an average of 5 days

Study Arms (2)

Control group:

NO INTERVENTION

Standard intensive care unit care without virtual reality stimulation.

Interventional group:

EXPERIMENTAL

Standard intensive care unit care and 30 minutes of virtual reality stimulation two times per day.

Other: Virtual Reality

Interventions

Virtual Reality OTHER

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.

Interventional group:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Floriane PUEL, Dr

  Hôpital Rangueil, CHU de Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Floriane PUEL, Dr

CONTACT

05 61 32 22 25; puel.f@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical interventional trial, randomized, monocentric in the Intensive Care Unit of Toulouse University Hospital.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 24, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)