Virtual Reality for Anxiety Management in Mechanically Vented Patients

University of Minnesota (UMN)

Status: Completed

Conditions: Situational Anxiety

Treatments: Device: Virtual Reality Technology

Study type: Interventional

Funder types: Other

Identifiers

NCT03169374

STUDY00000220

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age: 18 years or older

1. Mechanically ventilated; defined as having an endotracheal tube or tracheostomy and requiring continuous support from a mechanical ventilator.
2. Able to spontaneously maintain a state of wakefulness and alertness and able to follow commands
3. Able to communicate with research staff; defined as writing or head nods/shakes

Exclusion criteria

1. Delirious; defined as positive on the Confusion Assessment Method for the ICU (CAM-ICU +)
2. Expected to be liberated from ventilator within 12 hours of potential enrollment
3. Existence of skull injury or recent surgery (craniectomy) which precludes safely wearing VR visor
4. Impaired ability to see or hear, as determined by study investigator
5. Ventilator settings with positive end expiratory pressure (PEEP) greater than 10
6. Inability to be safely removed from physical restraints for VR (virtual reality) sessions
7. Chronic ventilator dependence prior to the present hospitalization
8. Lacking capacity to consent for one's self
9. Known difficult airway; based on review of intubation note
10. Tracheostomy performed within last seven days
11. Pre-existing symptoms overlapping with major symptoms of cyber-sickness: Headache, Vertigo (dizziness), Ataxia (tremor with movement), Nausea, Vomiting.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Virtual Reality Technology

Experimental group

Description:

Virtual Reality Therapy

Treatment:

Device: Virtual Reality Technology