Clinical trial NCT06101264: Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
Official title: Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2023-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. A retrospective chart review will also be performed on patients with idiopathic scoliosis who have undergone corrective surgery to serve as a historical control for the study. The retrospective arm of the study only includes patients who have not received a VR intervention.

Eligibility criteria: 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

Primary outcomes:
measure: Average subjective pain level on the 10-point Wong-Baker FACES pain scale
timeFrame: 3 times daily postoperatively until hospital discharge (up to 60 days postoperatively)
Secondary outcomes:
measure: Total amount of administered opioids during the post-operative period
timeFrame: From post-operative day 1 until hospital discharge (up to 60 days postoperatively)
measure: Average daily activity levels during the post-operative period measured through actigraphy.
timeFrame: Post-operative day 1 until hospital discharge (up to 60 days postoperatively)
measure: Average number of physical therapy sessions prior to receiving clearance by physical therapy staff
timeFrame: Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively)
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: David Hersh, MD
role: PRINCIPAL_INVESTIGATOR
References: