Anxiety, Pain, Virtual Reality
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of virtual reality (VR) distraction in patients undergoing interventional pain procedures in the prone position. VR has been shown to improve patient experience during interventional pain procedures, however, many of these procedures are done in the prone position making VR a challenge. This study will evaluate the effect of a VR headset and support in patients undergoing prone interventional pain procedures compared to control.
Interventions
OTHERVirtual Reality Headset
Patient uses a virtual reality headset and support during prone pain procedure
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years old or older, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure * English speaking and with the ability to understand oral and written instructions
Exclusion criteria
* Pregnant women * Prisoners * Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Score | Immediately before procedure | State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Score | Immediately before procedure, during procedure, and immediately after procedure | Anxiety score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain) |
| Pain Score | Immediately before procedure, during procedure, and immediately after procedure | Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain) |
| Global Impression of Change | Immediately after procedure | Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status) |
| Patient Experience Satisfaction | Immediately after procedure | Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction) |
| Sedation Requirements | During course of procedure | Amount of benzodiazepines and opioid medications given |
Countries
United States
Outcome results
None listed