Pain Procedures and Anxiolysis Via Distraction With Virtual Reality
PAIN-VR
Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic
1 other identifier
interventional
99
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2022
CompletedSeptember 28, 2022
September 1, 2022
1.5 years
June 9, 2020
September 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Anxiety Score
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)
Immediately before procedure and immediately after procedure.
Secondary Outcomes (4)
Pain Score
Immediately before procedure, during procedure, and immediately after procedure
Sedation Requirements
During course of procedure
Global Impression of Change
Immediately after procedure
Patient Experience Satisfaction
Immediately after procedure
Study Arms (2)
Virtual Reality Arm
EXPERIMENTALPatients undergo interventional pain procedure with virtual reality distraction
No Intervention Arm
NO INTERVENTIONPatients undergo interventional pain procedure without virtual reality distraction
Interventions
Patient wears a virtual reality headset during interventional pain procedure
Eligibility Criteria
You may qualify if:
- Patients aged over 18 years old, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
- English speaking
- Having the ability to understand oral and written instructions
- Willing to fill out psychometric surveys.
You may not qualify if:
- Pregnant women
- Prisoners
- Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Davis Interventional Pain Clinic
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naileshni Singh, MD
University of California, Davis
- PRINCIPAL INVESTIGATOR
John Sun, MD
University of California, Davis
- PRINCIPAL INVESTIGATOR
Michael Jung, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 18, 2020
Study Start
August 7, 2020
Primary Completion
February 9, 2022
Study Completion
February 9, 2022
Last Updated
September 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share