Virtual Reality Distraction for Reduction

Virtual Reality Distraction for Reduction in Acute Postoperative Pain

Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Placebo comparator: VR googles and the non reality experience; Device: Active Comparator: VR googles and the real VR program to enter act with and experience

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Fairview Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: VR googles using exposure sham program; The study groups will receive VR googles and the sham program	Device: Placebo comparator: VR googles and the non reality experience; parallel assignment (this arm will receive a static presentation in the same device)
Active Comparator: VR googles and the real VR program experience.; The study group will receive the VR googles and the real VR program experience.	Device: Active Comparator: VR googles and the real VR program to enter act with and experience; Parallel assignment (this arm will receive the full immersive virtual reality experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores (Numerical Rating Scale)	The primary outcome was post-intervention pain score, adjusted for the corresponding pre-intervention pain score. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain) We targeted 3 interventions per day for each patient, and thus, correspondingly 3 pre-post pain measurements per day. The reported value is the least squares mean calculated using a mixed model for repeated measures.	From the end of surgery until 48 hours after surgery or discharge, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption	The investigators measured total opioid consumption converted to morphine milligram equivalents (MME).	End of surgery to 72 hours after surgery.
Time Weighted Average Pain Score	Pain scores collected by nursing staff every 4 hours during the first 48 hours after surgery. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain). The reported value is the least squares mean calculated using a mixed model for repeated measures.	End of surgery to 48 hours after surgery
Perception of Video System Usability	Patient's perception of video system usability was 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.	Once between last intervention time and hospital discharge (up to 8 days after end of surgery)
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.	One week (7 days) after hospital discharge

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sabry Ayad, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): May 3, 2022

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 19-769; R44DA049640 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes