Back to resultsVirtual Reality Distraction for Reduction
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo comparator: VR googles and the non reality experience
Active Comparator: VR googles and the real VR program to enter act with and experience
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiology Physical Status 1-3;
- Scheduled for elective, primary total hip arthroplasty;
- Anticipated hospitalization of at least 1 night;
- Expected to require parenteral opioids for postoperative pain;
- Able to use IV PCA systems.
Exclusion criteria:
- History of chronic pain or care by a pain management specialist;
- Use of more than 30 mg/day of oral oxycodone (or equivalent);
- Greater than 12 weeks of current and continued opioid use;
- History of seizures, epilepsy, motion sickness, stroke, dementia;
- Non-English speaking;
- Women who are pregnant or breastfeeding;
- History of substance use disorder.
Sites / Locations
- Cleveland Clinic Fairview Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
VR googles using exposure sham program
VR googles and the real VR program experience.
Arm Description
The study groups will receive VR googles and the sham program
The study group will receive the VR googles and the real VR program experience.
Outcomes
Primary Outcome Measures
Pain Scores
The investigators will assess pain using NRS scores (0-10, with 10 being worst)
Secondary Outcome Measures
Total opioid consumption
the investigators will measure total opioid consumption converted to morphine milligram equivalents (MME).
Time weighted average pain score
The investigators will capture all pain scores measurements
Perception of video system usability
Patient's perception of video system usability will be assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use.
Post discharge analgesia.
Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04416555
Brief Title
Virtual Reality Distraction for Reduction
Official Title
Virtual Reality Distraction for Reduction in Acute Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.
Detailed Description
Specifically, the investigators propose to test the primary hypothesis that the use of AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1 point difference considered clinically important) compared to sham treatment on a 0-10 scale 15 minutes after each use in the first 48 hours after surgery or hospital discharge, whichever comes first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment (one arm will receive the full immersive virtual reality experience and the other arm will receive a static presentation in the same device)
Masking
ParticipantOutcomes Assessor
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR googles using exposure sham program
Arm Type
Placebo Comparator
Arm Description
The study groups will receive VR googles and the sham program
Arm Title
VR googles and the real VR program experience.
Arm Type
Active Comparator
Arm Description
The study group will receive the VR googles and the real VR program experience.
Intervention Type
Device
Intervention Name(s)
Placebo comparator: VR googles and the non reality experience
Intervention Description
parallel assignment (this arm will receive a static presentation in the same device)
Intervention Type
Device
Intervention Name(s)
Active Comparator: VR googles and the real VR program to enter act with and experience
Intervention Description
Parallel assignment (this arm will receive the full immersive virtual reality experience
Primary Outcome Measure Information:
Title
Pain Scores
Description
The investigators will assess pain using NRS scores (0-10, with 10 being worst)
Time Frame
From the end of surgery until 48 hours after surgery or discharge, whichever comes first
Secondary Outcome Measure Information:
Title
Total opioid consumption
Description
the investigators will measure total opioid consumption converted to morphine milligram equivalents (MME).
Time Frame
Within the first 72 hours.
Title
Time weighted average pain score
Description
The investigators will capture all pain scores measurements
Time Frame
Every 4 hours by standard of care during the first 48 hours after surgery or hospital discharge, whichever comes first using NRS scores (0-10, with 10 being worst).
Title
Perception of video system usability
Description
Patient's perception of video system usability will be assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use.
Time Frame
Once after the last assessment or hospital discharge, whichever comes first.
Title
Post discharge analgesia.
Description
Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes.
Time Frame
One week (7days) after hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiology Physical Status 1-3;
Scheduled for elective, primary total hip arthroplasty;
Anticipated hospitalization of at least 1 night;
Expected to require parenteral opioids for postoperative pain;
Able to use IV PCA systems.
Exclusion criteria:
History of chronic pain or care by a pain management specialist;
Use of more than 30 mg/day of oral oxycodone (or equivalent);
Greater than 12 weeks of current and continued opioid use;
History of seizures, epilepsy, motion sickness, stroke, dementia;
Non-English speaking;
Women who are pregnant or breastfeeding;
History of substance use disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabry Ayad, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
12. IPD Sharing Statement
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Virtual Reality Distraction for Reduction
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