Virtual Reality for Anxiety Management in Mechanically Vented Patients

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

Study Overview

• Status: Completed
• Conditions: Situational Anxiety
• Intervention / Treatment: Device: Virtual Reality Technology

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2017
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (ACTUAL): May 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Anxiety; Virtual Reality; Mechanical Ventilation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: STUDY00000220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No