Virtual Reality for Anxiety Management in Mechanically Vented Patients

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT03169374
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 21.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Situational Anxiety	Device: Virtual Reality Technology	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Virtual Reality for Anxiety Management in Mechanically Vented Patients
• Actual Study Start Date: Nov 9, 2017
• Actual Primary Completion Date: Aug 31, 2019
• Actual Study Completion Date: Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Reality Technology Virtual Reality Therapy	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.

Outcome Measures

Primary Outcome Measures

1. Incidence of safety events [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 Outcome Measures

1. Change in anxiety level during virtual reality treatment [Immediately following treatment session]

   Change in anxiety score from pre- to post-virtual reality treatment using a visual analog scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fairview Southdale Hospital	Edina	Minnesota	United States	55435

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: David Wacker, M.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03169374
• Other Study ID Numbers: STUDY00000220
• First Posted: May 30, 2017
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Minnesota: Virtual Reality; Mechanical Ventilation; Anxiety
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Oct 1, 2021