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Clinical Trials/NCT04416555
NCT04416555
Completed
Not Applicable

Virtual Reality Distraction for Reduction in Acute Postoperative Pain

The Cleveland Clinic1 site in 1 country113 target enrollmentAugust 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
The Cleveland Clinic
Enrollment
113
Locations
1
Primary Endpoint
Pain Scores (Numerical Rating Scale)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2020
End Date
May 3, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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;

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pain Scores (Numerical Rating Scale)

Time Frame: 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 Outcomes

  • Perception of Video System Usability(Once between last intervention time and hospital discharge (up to 8 days after end of surgery))
  • Time Weighted Average Pain Score(End of surgery to 48 hours after surgery)
  • Total Opioid Consumption(End of surgery to 72 hours after surgery.)
  • Post Discharge Analgesia.(One week (7 days) after hospital discharge)

Study Sites (1)

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