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Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population

Connecticut Children's Medical Center logo

Connecticut Children's Medical Center

Status

Completed

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Device: Virtual Reality
Device: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT06101264
23-064-CCMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Virtual Reality
Experimental group
Description:
Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.
Treatment:
Device: Virtual Reality
Control
Experimental group
Description:
Patients not receiving virtual reality intervention following corrective surgery for idiopathic scoliosis.
Treatment:
Device: Control

Trial documents
1

Trial contacts and locations

1

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Central trial contact

David Hersh, MD; Prabhath Mannam

Data sourced from clinicaltrials.gov

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