← Back to Search

Virtual Reality for Post-Operative Pain After Spinal Fusion

N/A

Waitlist Available

Led By Chantel Barney, PhD

Research Sponsored by Gillette Children's Specialty Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient with a diagnosis of adolescent idiopathic scoliosis (AIS) or a diagnosis of neuromuscular scoliosis

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 days

Awards & highlights

Study Summary

This trial will compare the effects of virtual reality on pain, medicine use, side effects, and hospital stay for people who had spine surgery.

Who is the study for?

This trial is for English-speaking patients undergoing spinal fusion at Gillette Children's Specialty Healthcare, specifically those with adolescent idiopathic scoliosis or neuromuscular scoliosis. It excludes those with motion sickness, epilepsy, a ventricular shunt, or severe cognitive impairments.Check my eligibility

What is being tested?

The study uses a randomized controlled trial (RCT) design to compare the effects of using Virtual Reality (VR) versus no VR on pain management, medication use, side effects and hospital stay length after spine fusion surgery.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from VR such as dizziness or nausea especially in individuals prone to motion sickness which is part of the exclusion criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with scoliosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Doses of pain medication

Timing of pain medication

Secondary outcome measures

Faces Pain Scale-Revised

Length of stay

Pain assessment scores

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality Post Spinal FusionExperimental Treatment1 Intervention

Patients randomized to the VR group will have the opportunity to utilize VR during the post operative period, and will also experience VR during research visits each day following surgery.

Group II: Standard of CareActive Control1 Intervention

Patients randomized to the non-VR condition will experience the usual standard of care following spinal fusion surgery. This will include 15-30 minutes of movie viewing during research visits.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality

2017

Completed Phase 3

~1630

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gillette Children's Specialty HealthcareLead Sponsor

30 Previous Clinical Trials

11,454 Total Patients Enrolled

Chantel Barney, PhDPrincipal InvestigatorGillette Children's Specialty Healthcare

1 Previous Clinical Trials

49 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include individuals under 25 years of age?

"This clinical trial is open to children aged 6 years or older and adolescents no older than 17."

Answered by AI

Are there any criteria for selecting enrollees in this research?

"This trial is seeking 80 participants between 6 and 17 years old who have had spinal fusion surgery."

Answered by AI

Can new participants still join this research effort?

"Data hosted on clinicaltrials.gov states that this investigation is no longer seeking volunteers and was last updated in July 2021. Nonetheless, there are 32 other studies actively recruiting patients at the moment."

Answered by AI

What is the ultimate goal of this medical experiment?

"This clinical trial is taking place over a four-day period, with the primary goal of examining the efficacy of pain relief medications. Secondary outcomes include evaluation using Faces Pain Scale-Revised (FPS-R), Visual Analogue Scale (VAS) and Nursing Pain Assessment Scores from medical records. The FPS-R assesses current intensity on a 0 to 10 scale, where zero indicates no pain and ten suggests extreme levels; it will be completed by both patient and parent when present at beginning of each daily research visit for VR or non-VR group. VAS evaluates multiple aspects such as anxiety experienced in past 24 hours, while nursing"

Answered by AI

Recent research and studies

PainJournal

Virtual Reality as an Adjunctive Pain Control During Burn Wound Care in Adolescent Patients

Hoffman, Hunter G., Jason N. Doctor, David R. Patterson, Gretchen J. Carrougher, and Thomas A. Furness. 2000. “Virtual Reality as an Adjunctive Pain Control During Burn Wound Care in Adolescent Patients”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0304-3959(99)00275-4.

Clinical Psychology ReviewJournal

The Effectiveness of Virtual Reality Distraction for Pain Reduction: A Systematic Review

Malloy, Kevin M., and Leonard S. Milling. 2010. “The Effectiveness of Virtual Reality Distraction for Pain Reduction: A Systematic Review”. Clinical Psychology Review. Elsevier BV. doi:10.1016/j.cpr.2010.07.001.

The Journal of PainJournal

Virtual Reality Helmet Display Quality Influences the Magnitude of Virtual Reality Analgesia

Hoffman, Hunter G., Eric J. Seibel, Todd L. Richards, Thomas A. Furness, David R. Patterson, and Sam R. Sharar. 2006. “Virtual Reality Helmet Display Quality Influences the Magnitude of Virtual Reality Analgesia”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2006.04.006.

PainJournal