MedDataX Logo

Virtual Reality Distraction for Reduction

NCT ID: NCT04416555

Last Updated: 2023-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2022-05-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Single (Outcomes Assessor)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VR googles using exposure sham program

The study groups will receive VR googles and the sham program

Group Type PLACEBO_COMPARATOR

Placebo comparator: VR googles and the non reality experience

Intervention Type DEVICE

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

VR googles and the real VR program experience.

The study group will receive the VR googles and the real VR program experience.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo comparator: VR googles and the non reality experience

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sabry Ayad, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37678233 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R44DA049640

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-769

Identifier Type: -

Identifier Source: org_study_id