Virtual Reality for Anxiety Management in Mechanically Vented Patients

NCT03169374 | Completed

• 1 other identifier: STUDY00000220
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Situational Anxiety

Keywords

Virtual Reality; Mechanical Ventilation; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in anxiety level during virtual reality treatment

  Immediately following treatment session

Study Arms (1)

Virtual Reality Technology

EXPERIMENTAL

Virtual Reality Therapy

Device: Virtual Reality Technology

Interventions

Virtual Reality Technology 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.

Virtual Reality Technology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older
• Mechanically ventilated; defined as having an endotracheal tube or tracheostomy and requiring continuous support from a mechanical ventilator.
• Able to spontaneously maintain a state of wakefulness and alertness and able to follow commands
• Able to communicate with research staff; defined as writing or head nods/shakes

You may not qualify if:

• Delirious; defined as positive on the Confusion Assessment Method for the ICU (CAM-ICU +)
• Expected to be liberated from ventilator within 12 hours of potential enrollment
• Existence of skull injury or recent surgery (craniectomy) which precludes safely wearing VR visor
• Impaired ability to see or hear, as determined by study investigator
• Ventilator settings with positive end expiratory pressure (PEEP) greater than 10
• Inability to be safely removed from physical restraints for VR (virtual reality) sessions
• Chronic ventilator dependence prior to the present hospitalization
• Lacking capacity to consent for one's self
• Known difficult airway; based on review of intubation note
• Tracheostomy performed within last seven days
• Pre-existing symptoms overlapping with major symptoms of cyber-sickness: Headache, Vertigo (dizziness), Ataxia (tremor with movement), Nausea, Vomiting.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• David Wacker, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 30, 2017
• Study Start: November 9, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)