An interventional study of Virtual Reality in Anxiety and Intensive Care Unit Syndrome, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care
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.
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.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 128 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
Standard intensive care unit care without virtual reality stimulation.
Standard intensive care unit care and 30 minutes of virtual reality stimulation two times per day.
Other: 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.
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
Time frame: 7 days
Difference in patient anxiety after using virtual reality
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
Time frame: between inclusion and the day 7
Evolution of the psychopathological status: depression
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
Time frame: 3 months
Evolution of the psychopathological status: anxiety
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
Time frame: 3 months
Evolution of the Sleep quality
Score to the Richards-Campbell Sleep Questionnaire (RCSQ) from 0 to 100 (0: worse sleep /100: best sleep
Time frame: every day through study completion, an average of 5 days
Evaluation of the Safety of using vitural reality in intensive care unit
Number of side effects that may occur during a VR session
Time frame: every day through study completion, an average of 5 days
Evaluation of the compliance
Number of virtual reality sessions actually performed by the patient in the intervention group
Time frame: 3 months
Plan to share: No
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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