Virtual Reality Distraction for Reduction

NCT04416555 | Completed Results FDA Device

• 2 other identifiers: 19-769R44DA049640
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Opioid Consumption

  End of surgery to 72 hours after surgery.

• Time Weighted Average Pain Score

  End of surgery to 48 hours after surgery

• Perception of Video System Usability

  Once between last intervention time and hospital discharge (up to 8 days after end of surgery)

• Post Discharge Analgesia.

  One week (7 days) after hospital discharge

Study Arms (2)

VR googles using exposure sham program

PLACEBO COMPARATOR

The study groups will receive VR googles and the sham program

Device: Placebo comparator: VR googles and the non reality experience

VR googles and the real VR program experience.

ACTIVE COMPARATOR

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

Interventions

Placebo comparator: VR googles and the non reality experience DEVICE

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

VR googles using exposure sham program

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

VR googles and the real VR program experience.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Related Publications (1)

• Araujo-Duran J, Kopac O, Montalvo Campana M, Bakal O, Sessler DI, Hofstra RL, Shah K, Turan A, Ayad S. Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial. Anesth Analg. 2024 Apr 1;138(4):751-759. doi: 10.1213/ANE.0000000000006642. Epub 2023 Sep 6.

  PMID: 37678233 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sabry Ayad
• Organization: Cleveland Clinic

Saayad@ccf.org

216.476.7052

Study Officials

• Sabry Ayad, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel assignment (one arm will receive the full immersive virtual reality experience and the other arm will receive a static presentation in the same device)

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: August 3, 2020
• Primary Completion: April 25, 2022
• Study Completion: May 3, 2022
• Last Updated: November 27, 2023
• Results First Posted: November 27, 2023

Record last verified: 2023-08

Locations

US (1)