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Virtual Reality for Post-Operative Recovery in Pediatric Scoliosis

N/A
Recruiting
Led By David Hersh, MD
Research Sponsored by Connecticut Children's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months
Be younger than 65 years old
Must not have
Chronic pain requiring the daily use of opioids for more than 2 weeks prior to the procedure
History of seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 times daily postoperatively until hospital discharge (up to 60 days postoperatively)
Awards & highlights

Summary

This trial looks at how virtual reality affects kids' post-op pain, drug use, and physical therapy after scoliosis surgery.

Who is the study for?
This trial is for pediatric patients aged 13-18 at Connecticut Children's who are undergoing surgery for idiopathic scoliosis. It excludes those with recent head or neck surgery, chronic opioid use, non-English speakers, seizure history, cognitive delays that affect VR use, and those with certain electronic medical devices.
What is being tested?
The study is testing the impact of virtual reality on pain perception, narcotic medication needs, and physical therapy progress in children after scoliosis surgery. The goal is to see if VR can improve post-operative recovery experiences.
What are the potential side effects?
Potential side effects may include discomfort from wearing a head-mounted display or specific reactions to virtual reality such as dizziness or nausea. However, these will be monitored during screening.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a teen (13-18) at Connecticut Children's getting surgery for scoliosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been using opioids daily for chronic pain for more than 2 weeks.
Select...
I have a history of seizures.
Select...
I cannot safely wear head-mounted devices due to my head or neck surgery.
Select...
I experienced side effects during the screening process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 times daily postoperatively until hospital discharge (up to 60 days postoperatively)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 times daily postoperatively until hospital discharge (up to 60 days postoperatively) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average subjective pain level on the 10-point Wong-Baker FACES pain scale
Secondary study objectives
Average daily activity levels during the post-operative period measured through actigraphy.
Average number of physical therapy sessions prior to receiving clearance by physical therapy staff
Total amount of administered opioids during the post-operative period

Trial Design

1Treatment groups
Experimental Treatment
Group I: Virtual Reality InterventionExperimental Treatment1 Intervention
Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality Intervention
2017
N/A
~240

Find a Location

Who is running the clinical trial?

University of ConnecticutOTHER
188 Previous Clinical Trials
160,261 Total Patients Enrolled
Connecticut Children's Medical CenterLead Sponsor
73 Previous Clinical Trials
26,564 Total Patients Enrolled
David Hersh, MDPrincipal InvestigatorConnecticut Children's Medical Center
~15 spots leftby Jan 2025
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