Virtual Reality After Pediatric Scoliosis Surgery

Not Applicable

Completed

• Conditions: Scoliosis Idiopathic; Pain, Postoperative
• Interventions: Device: Apple iPad; Device: Applied VR

• Registration Number: NCT04584970
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-14
• Study Start: 2020-12-08
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Results First Submitted: 2022-06-24
• Status Verified: 2022-07
• Results First Submitted QC: 2022-08-22
• Last Update Submitted: 2022-08-22
• Results First Posted: 2022-09-16
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iPad device	Apple iPad	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.
Virtual reality device	Applied VR	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.

Primary Outcome Measures

Name	Time	Method
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30	Recorded at end of intervention (T=30 minutes)	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.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10	Recorded at the 10 minute mark (T=10 minutes)	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.
Opioid PCA Use at T=0-30	Recorded during intervention (T=0-30 minutes)	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.
Opioid PCA Use at T=30-90	Recorded one hour after intervention is complete (T=30-90 minutes)	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.
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0	Recorded immediately prior to intervention (T=0 min)	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.
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30	Recorded at end of intervention (T=30 minutes)	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.
Pain Scores Via FACES Scale by Patient at Baseline	Recorded preoperatively as 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.
Pain Scores Via FLACC Scale by Research Assistant at Baseline	Recorded preoperatively as 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.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0	Recorded immediately prior to intervention (T=0 minutes)	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.
Opioid PCA Use at T=-60-0	Recorded for the hour prior to intervention (T=-60-0 minutes)	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.
Total Opioid Dose (in Milligram Morphine Equivalents)	From anesthesia end through hospital discharge, a total of approximately 2 days	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days	At approximately 7-10 days postoperatively	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.
Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours	At approximately 48-72 hours postoperatively	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.
Patient Satisfaction at 48-72 Hours	At approximately 48-72 hours postoperatively	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.
Electronic Device Use	Assessed at time of intervention on postoperative day #1	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.
Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form	Recorded preoperatively as baseline	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.
Patient Satisfaction at 7-10 Days	At approximately 7-10 days postoperatively	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.
Caregiver Satisfaction at 48-72 Hours	At approximately 48-72 hours postoperatively	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.
Caregiver Satisfaction at 7-10 Days	At approximately 7-10 days postoperatively	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.

Trial Locations

Locations (1)

University of North Carolina (UNC) Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States