Virtual Reality After Pediatric Scoliosis Surgery

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

Detailed Description
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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.

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

Conditions
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Scoliosis Idiopathic, Pain, Postoperative

Intervention / Treatment
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* Device: Applied VR
* Device: Apple iPad


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality device<br>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<br>* 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.<br>|
| Active Comparator: iPad device<br>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<br>* The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Distraction methods, Idiopathic scoliosis, Postoperative pain, Pediatric surgery