Situational Anxiety
Conditions
Keywords
Virtual Reality, Mechanical Ventilation, Anxiety
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.
Interventions
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.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of safety events | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety level during virtual reality treatment | Immediately following treatment session | Change in anxiety score from pre- to post-virtual reality treatment using a visual analog scale. |
Countries
United States
Outcome results
None listed