Virtual Reality for Anxiety Management in Mechanically Vented Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and feasibility of virtual reality for anxiety treatment in mechanically ventilated patients.

Detailed Description
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Mechanically ventilated patients (those on a breathing machine) often experience heightened levels of anxiety and discomfort. This is usually treated by using sedative medications, however these drugs often have unintended side effects. This study will investigate the safety and feasibility of using relaxing virtual reality environments for reduction of anxiety in mechanically ventilated patients.

Official Title
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Virtual Reality for Anxiety Management in Mechanically Vented Patients

Conditions
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Situational Anxiety

Intervention / Treatment
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* Device: Virtual Reality Technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or older Mechanically ventilated; defined as having an endotracheal tube or tracheostomy and requiring continuous support from a mechanical ventilator. Able to spontaneously maintain a state of wakefulness and alertness and able to follow commands Able to communicate with research staff; defined as writing or head nods/shakes Exclusion Criteria: Delirious; defined as positive on the Confusion Assessment Method for the ICU (CAM-ICU +) Expected to be liberated from ventilator within 12 hours of potential enrollment Existence of skull injury or recent surgery (craniectomy) which precludes safely wearing VR visor Impaired ability to see or hear, as determined by study investigator Ventilator settings with positive end expiratory pressure (PEEP) greater than 10 Inability to be safely removed from physical restraints for VR (virtual reality) sessions Chronic ventilator dependence prior to the present hospitalization Lacking capacity to consent for one's self Known difficult airway; based on review of intubation note Tracheostomy performed within last seven days Pre-existing symptoms overlapping with major symptoms of cyber-sickness: Headache, Vertigo (dizziness), Ataxia (tremor with movement), Nausea, Vomiting.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Technology<br>Virtual Reality Therapy | Device: Virtual Reality Technology<br>* Patients in this arm will participate in virtual reality sessions planned for 5 minutes at a time, during which they are shown relaxing virtual environments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of safety events | Occurrence rate of safety events, defined as cardiac arrhythmias, hypotension, hypertension, oxygen desaturation, falls to the floor, or unintentional removal of a medical tube or device. | Immediately following treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety level during virtual reality treatment | Change in anxiety score from pre- to post-virtual reality treatment using a visual analog scale. | Immediately following treatment session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Mechanical Ventilation, Anxiety