Virtual Reality for Anxiety Management in Mechanically Vented Patients

NCT ID: NCT03169374

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2019-08-31

Brief Summary

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

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.

Conditions

Situational Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Virtual Reality Technology

Virtual Reality Therapy

Group Type: EXPERIMENTAL

Virtual Reality Technology

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wacker, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Fairview Southdale Hospital

Edina, Minnesota, United States

Countries

United States

Other Identifiers

STUDY00000220

Identifier Type: -

Identifier Source: org_study_id