Back to results

Virtual Reality for Anxiety Management in Mechanically Vented Patients

Primary Purpose

Situational Anxiety

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Reality Technology

About this trial

This is an interventional device feasibility trial for Situational Anxiety focused on measuring Virtual Reality, Mechanical Ventilation, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Fairview Southdale Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality Technology

Arm Description

Virtual Reality Therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in anxiety level during virtual reality treatment

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

Full Information

NCT ID

NCT03169374

First Posted

May 17, 2017

Last Updated

September 27, 2021

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT03169374

Brief Title

Virtual Reality for Anxiety Management in Mechanically Vented Patients

Official Title

Virtual Reality for Anxiety Management in Mechanically Vented Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

November 9, 2017 (Actual)

Primary Completion Date

August 31, 2019 (Actual)

Study Completion Date

August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Situational Anxiety

Keywords

Virtual Reality, Mechanical Ventilation, Anxiety

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Reality Technology

Arm Type

Experimental

Arm Description

Virtual Reality Therapy

Intervention Type

Device

Intervention Name(s)

Virtual Reality Technology

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of safety events

Description

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.

Time Frame

Immediately following treatment session

Secondary Outcome Measure Information:

Title

Change in anxiety level during virtual reality treatment

Description

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

Time Frame

Immediately following treatment session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Wacker, M.D.

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fairview Southdale Hospital

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Virtual Reality for Anxiety Management in Mechanically Vented Patients

We'll reach out to this number within 24 hrs