N/A N=23 Randomized Supportive Care

Virtual Reality After Pediatric Scoliosis Surgery

Scoliosis Idiopathic · Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT04584970 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2022

Primary outcome: Primary: Pain Scores Via FACES Scale by Patient at Baseline — 0.91; 0.92 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Applied VR (Device); Apple iPad (Device)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Scores Via FACES Scale by Patient at Baseline	0.91; 0.92	—
PRIMARY Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0	5.00; 4.22	—
PRIMARY Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30	3.80; 3.55	—
PRIMARY Pain Scores Via FLACC Scale by Research Assistant at Baseline	0; 1.5	—
PRIMARY Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0	0.60; 0.33	—
PRIMARY Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10	0; 0.44	—
PRIMARY Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30	0; 0	—
PRIMARY Opioid PCA Use at T=-60-0	—	—
PRIMARY Opioid PCA Use at T=0-30	—	—
PRIMARY Opioid PCA Use at T=30-90	—	—
PRIMARY Total Opioid Dose (in Milligram Morphine Equivalents)	4.74; 5.27	—
SECONDARY Electronic Device Use	20.33; 26.38	—
SECONDARY Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form	11.64; 13.27	—
SECONDARY Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours	—	—
SECONDARY Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days	—	—
SECONDARY Patient Satisfaction at 48-72 Hours	—	—
SECONDARY Patient Satisfaction at 7-10 Days	—	—
SECONDARY Caregiver Satisfaction at 48-72 Hours	—	—
SECONDARY Caregiver Satisfaction at 7-10 Days	—	—

Summary

The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.

Eligibility Criteria

Inclusion Criteria

Subjects age 11 - 17 years of age
Patients undergoing idiopathic scoliosis surgery on Enhanced Recovery after Surgery (ERAS) spine protocol (which includes postoperative PCA)

Exclusion Criteria

Patient/caregiver refusal
Patients with developmental delay
Patients with seizure disorder
Non-English-speaking patients
Patients with daily opioid use >/= two weeks
Patients with uncorrected visual or hearing impairment
Patients admitted to pediatric intensive care unit on postoperative day #1

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04584970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.