Virtual Reality to Reduce the Anxiety in Critically Ill Patient

NCT ID: NCT06747793

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-01-31

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.

Detailed Description

Physicians have recently started using immersive VR as an adjunctive non-invasive and non-pharmacological pain control and anxiolysis technique, but the literature on this topic in the adult ICU is quite sparse. In a pilot study, Gerber et al showed the feasibility and acceptance of VR stimulation as a new non-pharmacological intervention to comfort patients during their stay in the ICU and the results appear promising [11]. In our view, the management of anxiety related to healthcare interventions remains a major global challenge and it will be interesting to assess the use of VR in a chronic daily use in the ICU adult patients. Our study will be conducted in the adult intensive care unit of the University of Toulouse, France. All patients who meet the inclusion criteria will be randomized. There will be two distinct groups: the control group will receive standard ICU care, whereas the intervention group will, in addition to the standard ICU care, will receive relaxing VR stimulation two times a day. The intervention will be performed by trained ICU nurses. Anxiety will be assessed by the Visual Analogue Scale for Anxiety (VAS-A) twice by day (morning and evening), sleep quality with the Richards-Campbell Sleep Questionnaire (RCSQ) every morning, depression, and anxiety with the Hamilton Depression Rating Scale (HDRS) and the Hamilton Anxiety Rating Scale (HAM-A) at 3-months after the inclusion. Each patient's heart rate, blood pressure, respiration rate, SatO2, and physical or neurocognitive side effects were used to evaluate if the VR sessions will have any effect on physiology.

Conditions

Anxiety; Intensive Care Unit Syndrome

Study Design

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

Study Groups

Control group:

Standard intensive care unit care without virtual reality stimulation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional group:

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

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Floriane PUEL, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Rangueil, CHU de Toulouse

Locations

University Hospital of Toulouse

Toulouse, , France

Countries

France

Central Contacts

Floriane PUEL, Dr

Role: CONTACT

puel.f@chu-toulouse.fr

05 61 32 22 25

Facility Contacts

Floriane PUEL, MD

Role: primary

Other Identifiers

RC31/23/0617

Identifier Type: -

Identifier Source: org_study_id