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Completed

NCT Number: NCT04416555

Virtual Reality Distraction for Reduction

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo comparator: VR googles and the non reality experience

Device

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 experience

Device

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

Primary outcomes

  1. 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

  1. Total Opioid Consumption

    Time frame: End of surgery to 72 hours after surgery.

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

  2. Time Weighted Average Pain Score

    Time frame: 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.

  3. Perception of Video System Usability

    Time frame: 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.

  4. Post Discharge Analgesia.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Virtual Reality Distraction for Reduction in Acute Postoperative Pain

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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