Clinical trial NCT04584970: Virtual Reality After Pediatric Scoliosis Surgery
Official title: Evaluation of Virtual Reality Intervention After Pediatric Idiopathic Scoliosis Surgery to Reduce Postoperative Pain and Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis Idiopathic
Pain, Postoperative
Keywords: Virtual reality
Distraction methods
Idiopathic scoliosis
Postoperative pain
Pediatric surgery
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 23
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Purpose: To evaluate postoperative pain scores and postoperative opioid use in pediatric idiopathic scoliosis surgical patients using virtual reality (VR) as a method of immersive distraction compared with standard electronic use postoperatively.

Participants: Patients age 11-17 undergoing idiopathic scoliosis surgery on Enhanced Recovery After Surgery (ERAS) spine protocol at our institution.

Procedures (methods): Participants will be randomized to intervention arm (VR) or control arm (iPad). Baseline pain and anxiety scores will be assessed. On postoperative day 1, each patient will receive a visit by the research assistant who will assess pain scores, PCA use, etc. The intervention group will be offered a VR device for up to 30 minutes. The control group will be offered an iPad for up to 30 minutes. This visit will be performed twice on postoperative day 1. Follow up survey will be conducted at 48-72 hours and 7-10 days postoperatively.

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

Primary outcomes:
measure: Pain Scores Via FACES Scale by Patient at Baseline
timeFrame: Recorded preoperatively as baseline
measure: Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0
timeFrame: Recorded immediately prior to intervention (T=0 min)
measure: Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30
timeFrame: Recorded at end of intervention (T=30 minutes)
measure: Pain Scores Via FLACC Scale by Research Assistant at Baseline
timeFrame: Recorded preoperatively as baseline
measure: Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0
timeFrame: Recorded immediately prior to intervention (T=0 minutes)
measure: Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10
timeFrame: Recorded at the 10 minute mark (T=10 minutes)
measure: Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30
timeFrame: Recorded at end of intervention (T=30 minutes)
measure: Opioid PCA Use at T=-60-0
timeFrame: Recorded for the hour prior to intervention (T=-60-0 minutes)
measure: Opioid PCA Use at T=0-30
timeFrame: Recorded during intervention (T=0-30 minutes)
measure: Opioid PCA Use at T=30-90
timeFrame: Recorded one hour after intervention is complete (T=30-90 minutes)
measure: Total Opioid Dose (in Milligram Morphine Equivalents)
timeFrame: From anesthesia end through hospital discharge, a total of approximately 2 days
Secondary outcomes:
measure: Electronic Device Use
timeFrame: Assessed at time of intervention on postoperative day #1
measure: Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form
timeFrame: Recorded preoperatively as baseline
measure: Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours
timeFrame: At approximately 48-72 hours postoperatively
measure: Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days
timeFrame: At approximately 7-10 days postoperatively
measure: Patient Satisfaction at 48-72 Hours
timeFrame: At approximately 48-72 hours postoperatively
measure: Patient Satisfaction at 7-10 Days
timeFrame: At approximately 7-10 days postoperatively
measure: Caregiver Satisfaction at 48-72 Hours
timeFrame: At approximately 48-72 hours postoperatively
measure: Caregiver Satisfaction at 7-10 Days
timeFrame: At approximately 7-10 days postoperatively
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Specht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.
citation: Eijlers R, Legerstee JS, Dierckx B, Staals LM, Berghmans J, van der Schroeff MP, Wijnen RM, Utens EM. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Sep 11;6(9):e174. doi: 10.2196/resprot.7617.
citation: Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.
citation: Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain intensity during venipuncture. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12201. Epub 2017 Nov 20.
citation: Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.
citation: Won AS, Tataru CA, Cojocaru CM, Krane EJ, Bailenson JN, Niswonger S, Golianu B. Two Virtual Reality Pilot Studies for the Treatment of Pediatric CRPS. Pain Med. 2015 Aug;16(8):1644-7. doi: 10.1111/pme.12755. Epub 2015 Apr 30. No abstract available.