Pain Procedures and Anxiolysis Via Distraction With Virtual Reality (PAIN-VR)
Primary Purpose
Virtual Reality, Anxiety, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Headset Distraction
Sponsored by
About this trial
This is an interventional treatment trial for Virtual Reality
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant women
- Prisoners
- Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
Sites / Locations
- UC Davis Interventional Pain Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Reality Arm
No Intervention Arm
Arm Description
Patients undergo interventional pain procedure with virtual reality distraction
Patients undergo interventional pain procedure without virtual reality distraction
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Pain Score
Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)
Sedation Requirements
Amount of benzodiazepines and opioid medications given
Global Impression of Change
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
Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)
Full Information
NCT ID
NCT04437173
First Posted
June 9, 2020
Last Updated
September 26, 2022
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT04437173
Brief Title
Pain Procedures and Anxiolysis Via Distraction With Virtual Reality
Acronym
PAIN-VR
Official Title
Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Anxiety, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Arm
Arm Type
Experimental
Arm Description
Patients undergo interventional pain procedure with virtual reality distraction
Arm Title
No Intervention Arm
Arm Type
No Intervention
Arm Description
Patients undergo interventional pain procedure without virtual reality distraction
Intervention Type
Device
Intervention Name(s)
Virtual Reality Headset Distraction
Intervention Description
Patient wears a virtual reality headset during interventional pain procedure
Primary Outcome Measure Information:
Title
Anxiety Score
Description
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)
Time Frame
Immediately before procedure and immediately after procedure.
Secondary Outcome Measure Information:
Title
Pain Score
Description
Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)
Time Frame
Immediately before procedure, during procedure, and immediately after procedure
Title
Sedation Requirements
Description
Amount of benzodiazepines and opioid medications given
Time Frame
During course of procedure
Title
Global Impression of Change
Description
Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)
Time Frame
Immediately after procedure
Title
Patient Experience Satisfaction
Description
Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)
Time Frame
Immediately after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Pregnant women
Prisoners
Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naileshni Singh, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Sun, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Jung, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Interventional Pain Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pain Procedures and Anxiolysis Via Distraction With Virtual Reality
We'll reach out to this number within 24 hrs