Virtual Reality for Anxiety Management in Mechanically Vented Patients

Situational Anxiety Clinical Trial

Official title:

Virtual Reality for Anxiety Management in Mechanically Vented Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169374
• Other study ID #: STUDY00000220
• Status: Completed
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: September 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Situational Anxiety

Intervention

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.

Locations

Country	Name	City	State
United States	Fairview Southdale Hospital	Edina	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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