Virtual Reality After Pediatric Scoliosis Surgery (VRAS-PS)

Evaluation of Virtual Reality Intervention After Pediatric Idiopathic Scoliosis Surgery to Reduce Postoperative Pain and Opioid Consumption

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Scoliosis Idiopathic
• Intervention / Treatment: Device: Applied VR; Device: Apple iPad

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina (UNC) Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Virtual reality device; 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; 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.
ACTIVE_COMPARATOR: iPad device; 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; The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electronic Device Use	VR device or iPad use in minutes. Minimal 0 minutes, maximum 60 minutes (30 minutes x 2 sessions). A higher number indicates more electronic device use, which is neither a better or worse outcome, but rather provides information about whether devices were used for the full allotted time or not.	Assessed at time of intervention on postoperative day #1
Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form	The State-Trait Anxiety Inventory (STAI) Short Form scoring tool is a self-report questionnaire. It contains 6 statements (i.e., 'I feel calm', with 1=Not at all, 2=Somewhat, 3=Moderately, 4=Very much). Scores range from 6-24, with 6 signifying no anxiety and 24 points signifying the highest level of anxiety. Higher score indicates a worse outcome.	Recorded preoperatively as baseline
Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours	A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) form via a phone call, email or in person from a member of the research team. There are 11 items on a five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55, with higher scores indicating more negative behavioral changes. Higher score indicates a worse outcome.	At approximately 48-72 hours postoperatively
Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days	A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) form via a phone call, email or in person from a member of the research team. There are 11 items on a five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55, with higher scores indicating more negative behavioral changes. Higher score indicates a worse outcome.	At approximately 7-10 days postoperatively
Patient Satisfaction at 48-72 Hours	To assess patient satisfaction, qualitative satisfaction will be documented. Patient satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Patients will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified.	At approximately 48-72 hours postoperatively
Patient Satisfaction at 7-10 Days	To assess patient satisfaction, qualitative satisfaction will be documented. Patient satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Patients will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified.	At approximately 7-10 days postoperatively
Caregiver Satisfaction at 48-72 Hours	To assess caregiver satisfaction, qualitative satisfaction will be documented. Patient and caregiver satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Caregivers will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their child's experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified.	At approximately 48-72 hours postoperatively
Caregiver Satisfaction at 7-10 Days	To assess caregiver satisfaction, qualitative satisfaction will be documented. Patient and caregiver satisfaction and overall experience are commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use of VR as a method of pain control will be one of the outcomes. Caregivers will simply be asked by the researcher assistant, qualitatively, how satisfied they were with their child's experience with the device, and their comments will be recorded. Collected answers will be divided into positive and negative comments, and any emerging themes will be identified.	At approximately 7-10 days postoperatively

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Brian Specht, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2020
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Idiopathic scoliosis; Virtual reality; Postoperative pain; Pediatric surgery; Distraction methods
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Pain, Postoperative; Scoliosis
• Other Study ID Numbers: 20-0696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to marley.lawrence@unchealth.unc.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following publication
• IPD Sharing Access Criteria: Researchers who present a methodologically sound proposal and return a signed data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes