Clinical trial NCT06747793: Virtual Reality to Reduce the Anxiety in Critically Ill Patient
Official title: Evaluation of the Use of Virtual Reality to Reduce Anxiety in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Intensive Care Unit Syndrome
Keywords: Intensive care unit
virtual reality
anxiety
depression
sleep quality
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical interventional trial, randomized, monocentric in the Intensive Care Unit of Toulouse University Hospital.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patients' anxiety level after using virtual reality
timeFrame: 7 days
Secondary outcomes:
measure: Difference in patient anxiety after using virtual reality
timeFrame: between inclusion and the day 7
measure: Evolution of the psychopathological status: depression
timeFrame: 3 months
measure: Evolution of the psychopathological status: anxiety
timeFrame: 3 months
measure: Evolution of the Sleep quality
timeFrame: every day through study completion, an average of 5 days
measure: Evaluation of the Safety of using vitural reality in intensive care unit
timeFrame: every day through study completion, an average of 5 days
measure: Evaluation of the compliance
timeFrame: 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: Hôpital Rangueil, CHU de Toulouse
name: Floriane PUEL, Dr
role: PRINCIPAL_INVESTIGATOR
References: