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Virtual Reality for Anxiety Management in Mechanically Vented Patients

Not Applicable
Completed
Conditions
Situational Anxiety
Interventions
Device: Virtual Reality Technology
Registration Number
NCT03169374
Lead Sponsor
University of Minnesota
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Virtual Reality TechnologyVirtual Reality TechnologyVirtual Reality Therapy
Primary Outcome Measures
NameTimeMethod
Incidence of safety eventsImmediately following treatment session

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
NameTimeMethod
Change in anxiety level during virtual reality treatmentImmediately following treatment session

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

Trial Locations

Locations (1)

Fairview Southdale Hospital

🇺🇸

Edina, Minnesota, United States

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