Virtual Reality After Pediatric Scoliosis Surgery

NCT04584970 | Completed Results FDA Device

• 1 other identifier: 20-0696
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scoliosis Idiopathic; Pain, Postoperative

Keywords

Virtual reality; Distraction methods; Idiopathic scoliosis; Postoperative pain; Pediatric surgery

Outcome Measures

Primary Outcomes (11)

• Pain Scores Via FACES Scale by Patient at Baseline

  All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome.

  Recorded preoperatively as baseline

• Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0

  All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.

  Recorded immediately prior to intervention (T=0 min)

• Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30

  All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately after first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.

  Recorded at end of intervention (T=30 minutes)

• Pain Scores Via FLACC Scale by Research Assistant at Baseline

  The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome.

  Recorded preoperatively as baseline

• Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0

  The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.

  Recorded immediately prior to intervention (T=0 minutes)

• Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10

  The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately during first intervention exposure (T=10 min) during 1 30-minute session on day 1 postoperatively.

  Recorded at the 10 minute mark (T=10 minutes)

• Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30

  The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Participants were allowed to play/interact with intervention for up to 30 minutes. Assessed immediately following first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.

  Recorded at end of intervention (T=30 minutes)

• Opioid PCA Use at T=-60-0

  Opioid use via Patient-Controlled Analgesia (PCA) pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.

  Recorded for the hour prior to intervention (T=-60-0 minutes)

• Opioid PCA Use at T=0-30

  Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.

  Recorded during intervention (T=0-30 minutes)

• Opioid PCA Use at T=30-90

  Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.

  Recorded one hour after intervention is complete (T=30-90 minutes)

• Total Opioid Dose (in Milligram Morphine Equivalents)

  The amount of opioids used by the patient will be recorded in all subjects and converted into milligram morphine equivalents based on chart reviews. This collection method was added to replace PCA pump usage unavailability.

  From anesthesia end through hospital discharge, a total of approximately 2 days

Secondary Outcomes (8)

• Electronic Device Use

  Assessed at time of intervention on postoperative day #1

• Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form

  Recorded preoperatively as baseline

• Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours

  At approximately 48-72 hours postoperatively

• Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days

  At approximately 7-10 days postoperatively

• Patient Satisfaction at 48-72 Hours

  At approximately 48-72 hours postoperatively

Study Arms (2)

Virtual reality device

EXPERIMENTAL

Participants will be offered a virtual reality (VR) device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games.

Device: Applied VR

iPad device

ACTIVE COMPARATOR

Participants will be offered an iPad device for up to 30 minutes for two separate sessions on postoperative day 1. The device will be pre-loaded with a variety of vetted and screened age-appropriate games.

Device: Apple iPad

Interventions

Applied VR DEVICE

The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.

Virtual reality device

Apple iPad DEVICE

The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.

iPad device

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina (UNC) Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (6)

• Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can Fam Physician. 2017 Dec;63(12):932-934.

  PMID: 29237632 BACKGROUND

• 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.

  PMID: 28893727 BACKGROUND

• 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.

  PMID: 29053848 BACKGROUND

• 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.

  PMID: 29155488 BACKGROUND

• 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.

  PMID: 28975600 BACKGROUND

• 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.

  PMID: 25930099 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Jacob Nelson
• Organization: University of North Carolina at Chapel Hill

jacob14@live.unc.edu

704-677-3801

Study Officials

• Brian Specht, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: December 8, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following publication
• Access Criteria: Researchers who present a methodologically sound proposal and return a signed data access agreement

Locations

US (1)