Health TrialsbyHealthPanel

Virtual Reality to Reduce the Anxiety in Critically Ill Patient

ConditionsAnxietyIntensive Care Unit Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality

    Other intervention

    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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Control group:No intervention 0 interventions
Group B: Interventional group:Experimental treatment 1 intervention

Trial outcomes

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

Time frame
7 days

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: