Virtual Reality Distraction for Reduction

Not Applicable

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT04416555
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Study Start: 2020-08-03
• Primary Completion: 2022-04-25
• Study Completion: 2022-05-03
• Status Verified: 2023-08
• Results First Submitted: 2023-08-13
• Results First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Results First Posted: 2023-11-27
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Scores (Numerical Rating Scale)	From the end of surgery until 48 hours after surgery or discharge, whichever comes first	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.

Secondary Outcome Measures

Name	Time	Method
Perception of Video System Usability	Once between last intervention time and hospital discharge (up to 8 days after end of surgery)	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.
Post Discharge Analgesia.	One week (7 days) after hospital discharge	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.
Total Opioid Consumption	End of surgery to 72 hours after surgery.	The investigators measured total opioid consumption converted to morphine milligram equivalents (MME).
Time Weighted Average Pain Score	End of surgery to 48 hours after surgery	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.

Trial Locations

Locations (1)

Cleveland Clinic Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States