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OpenTrials
Completed

NCT Number: NCT03169374

Virtual Reality for Anxiety Management in Mechanically Vented Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of safety events

    Time frame: Immediately 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 outcomes

  1. Change in anxiety level during virtual reality treatment

    Time frame: Immediately following treatment session

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2017
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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