Coping After Pediatric Scoliosis Surgery

Study Overview
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Brief Summary
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This is a prospective, randomized controlled trial evaluating the efficacy of expanded patient education and coping skills on pain management following multilevel pediatric spinal surgery. The intervention will include a smartphone- based platform and a comprehensive library of peri-operative educational and coping skills videos as a means for better addressing the psychosocial elements of a child's individual pain experience. The study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.

Official Title
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Coping After Pediatric Scoliosis Surgery: How Does it Affect Pain and Function?

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Other: Video Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach Exclusion Criteria: Non-English speaking Non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic. Other comorbidity, including developmental delay. Any surgical complication that results in significant divergence from our institution's standard scoliosis pathway. Unplanned admission within 6 weeks of index operation. Active treatment psychotherapy and/or cognitive behavioral therapy for any reason

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized Controlled Clinical Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Routine, standard-of-care treatment | Other: Control<br>* Routine, Standard-of-Care<br>|
| Experimental: Video Intervention<br>Routine, standard-of-care PLUS peri-operative video series | Other: Video Intervention<br>* Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Operative Pain | Outcome #1 will evaluate the intervention's impact on post-operative pain via completion of the computer-adaptive NIH PROMIS measures on pain intensity and pain behavior. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively | 
| Post-Operative Pain | Outcome #2 will evaluate the intervention's impact on a proxy for post-operative pain via completion of a 1-question survey on recent opioid consumption. The question is formatted as a 5-point Likert scale, scored 1-5, with higher scores indicating more frequent opioid consumption. | Up to 6-weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes - Global Health | Outcome #3 will measure patient reported outcomes via administration of the computer adaptive NIH PROMIS measures for global health. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores for this measure will be converted to T-scores via the NIH's published guidelines. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively | 
| Patient Reported Outcomes - Mobility | Outcome #4 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for mobility For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively | 
| Patient Reported Outcomes - Positive Affect | Outcome #5 will measure patient reported outcomes via completion of the computer-adaptive NIH PROMIS measure for positive affect. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively | 
| Patient Reported Outcomes - Physical Activity | Outcome #6 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for physical activity. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively | 
| Patient Reported Outcomes - Strength Impact | Outcome #7 will measure patient reported outcomes and functional status via completion of the computer-adaptive NIH PROMIS measure for strength impact. For each of the PROMIS measures, a score of 50 is the average for the United States general population with a standard deviation of 10. All scores are converted to T-scores. The T-score and standard error are automatically reported after completion of the computer-adaptive test. A higher PROMIS T-score represents more of the concept being measured. As each patient will have a pre-operative baseline score, the difference between pre- and post-operative scores will be utilized for all further analysis, with a difference of 10 points (1-standard deviation) scored as the minimal clinically significant difference. | Up to 6-weeks post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Function, Pediatric, Scoliosis, Scoliosis Surgery, Spinal Fusion, Idiopathic Scoliosis, Coping, Coping Skills, Education, Video Intervention, Randomized, Prospective, Satisfaction, Adolescent, Opioid