Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
- Conditions
- Adolescent Idiopathic Scoliosis
- Registration Number
- NCT06101264
- Lead Sponsor
- Connecticut Children's Medical Center
- Brief Summary
The purpose of this study is to assess the effect of virtual reality on subjective post-operative pain, total inpatient narcotic administration, and mobilization with physical therapy in pediatric patients who have undergone surgical correction for idiopathic scoliosis.
- Detailed Description
All pediatric patients (ages 13-18) at Connecticut Children's Medical Center undergoing corrective scoliosis surgery for idiopathic scoliosis are eligible and will be approached for consent and inclusion into the study. This is a prospective pilot study, and all enrolled patients will receive a virtual reality (VR) intervention using a commercially available device manufactured by Oculus. The VR software will simulate a low physical load environment, such as an underwater space exploration game. Starting on postoperative day 1, the prospective cohort will undergo a 20-minute VR session 30 minutes prior to each physical therapy session. There will be two physical therapy sessions scheduled daily for the participant. Outcome measures will be assessed before and after the VR session and after the physical therapy session. The following procedures will continue daily until the participant is cleared for hospital discharge. Patients that met study eligibility but elected not to participate in the VR intervention were analyzed as the control group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months
- History of seizures
- Cognitive developmental delay precluding participation in VR
- Head or neck surgery that does not allow a head-mounted display to be worn safely
- Chronic pain requiring the daily use of opioids for more than 2 weeks prior to the procedure
- Non-English speakers
- Side effects during screening
- Patients with vagal nerve stimulators, cardiac pacemakers, and/or cochlear implants that may receive interference from the VR device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Average Change in Subjective Pain Level Using a 10 Point Likert Scale 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively) This tool uses a 10-point scale that ranges from 0 (no pain) to 10 (worst possible pain). Pain will be assessed using this tool before and after every physical therapy session. The change in pain before and after each physical therapy session will be calculated and averaged across each patient.
- Secondary Outcome Measures
Name Time Method Total Amount of Administered Opioids During the Post-operative Period From post-operative day 1 until hospital discharge (up to 60 days postoperatively) Opioid utilization will be assessed by calculating the total inpatient dose of opioids administered (as documented in the electronic medical record) during the post-operative period, starting from post-operative day 1 until hospital discharge.
Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively) In the postoperative stage, each participant will receive two physical therapy sessions daily. Physical therapy sessions will continue daily until the participant is given clearance by the physical therapy team. To assess the mobilization of participants postoperatively, the total number of physical therapy sessions the participants attend prior to receiving clearance will be noted. The number of total attended physical therapy sessions during the postoperative stage will be averaged across all participants.
Related Research Topics
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Trial Locations
- Locations (1)
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Connecticut Children's Medical Center🇺🇸Hartford, Connecticut, United StatesDavid Hersh, MDContact860-545-8373dhersh@connecticutchildrens.orgPrabhath MannamContact8607092371pmannam@uchc.edu
