Virtual Reality to Reduce the Anxiety in Critically Ill Patient

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Intensive Care Unit Syndrome

• Registration Number: NCT06747793
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Study Start: 2025-02
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Difference in patient anxiety after using virtual reality	between inclusion and the day 7	Visual Analogue Scale for Anxiety (VAS-A) variations between inclusion and the day 7. The VAS A is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety
Evolution of the psychopathological status: depression	3 months	Score to the Hamilton Depression Rating Scale (HDRS) with 16 items from 0 (no symptom) to 4 (high symptom of depression) with a total score from 0 to 30: 0 no depression / 30: depression maximum
Evolution of the psychopathological status: anxiety	3 months	Score to the Hamilton Anxiety Rating Scale (HAM-A) with 14 items rom 0 (no symptom) to 4 (high symptom of depression) with a total score from 0 to 56: 0 no anxiety /56: anxiety maximum
Evolution of the Sleep quality	every day through study completion, an average of 5 days	Score to the Richards-Campbell Sleep Questionnaire (RCSQ) from 0 to 100 (0: worse sleep /100: best sleep
Evaluation of the Safety of using vitural reality in intensive care unit	every day through study completion, an average of 5 days	Number of side effects that may occur during a VR session
Evaluation of the compliance	3 months	Number of virtual reality sessions actually performed by the patient in the intervention group

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France