Adolescent Idiopathic Scoliosis Clinical Trial
Official title:
Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility | Inclusion Criteria: - All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Connecticut Children's Medical Center | University of Connecticut |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average subjective pain level on the 10-point Wong-Baker FACES pain scale | The Wong-Baker FACES pain scale is a validated and widely used tool to assess subjective pain levels in children and adults. 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 each virtual reality intervention and after every physical therapy session. The assessed pain level at each time point will be averaged across each day and across all of the participants. | 3 times daily postoperatively until hospital discharge (up to 60 days postoperatively) | |
Secondary | Total amount of administered opioids during the post-operative period | 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. | From post-operative day 1 until hospital discharge (up to 60 days postoperatively) | |
Secondary | Average daily activity levels during the post-operative period measured through actigraphy. | During the post-operative stage, the participants will wear an actigraphy watch. This device will measure the participant's activity levels throughout the day. Following discharge, the daily average activity level will be calculated. | Post-operative day 1 until hospital discharge (up to 60 days postoperatively) | |
Secondary | Average number of physical therapy sessions prior to receiving clearance by physical therapy staff | 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. | Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively) |
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