Virtual Reality for Anxiety Management in Mechanically Vented Patients

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2019

Detailed 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.

Interventions

  • Device: Virtual Reality Technology
    • 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.

Arms, Groups and Cohorts

  • Experimental: Virtual Reality Technology
    • Virtual Reality Therapy

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of safety events
    • Time Frame: Immediately following treatment session
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Minnesota
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Wacker, M.D., Principal Investigator, University of Minnesota

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