Virtual Reality Distraction for Reduction

The Cleveland Clinic113 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

113

Conditions

Postoperative Pain

Interventions

Placebo comparator: VR googles and the non reality experienceDEVICE

parallel assignment (this arm will receive a static presentation in the same device)

Active Comparator: VR googles and the real VR program to enter act with and experienceDEVICE

Parallel assignment (this arm will receive the full immersive virtual reality experience

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: From the end of surgery until 48 hours after surgery or discharge, whichever comes first

Secondary Outcomes

Total Opioid Consumption

The investigators measured total opioid consumption converted to morphine milligram equivalents (MME).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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