Coping After Pediatric Scoliosis Surgery

Not Applicable

Completed

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Other: Video Intervention; Other: Control

• Registration Number: NCT04063670
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-05-11
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Intervention	Video Intervention	Routine, standard-of-care PLUS peri-operative video series
Control	Control	Routine, standard-of-care treatment

Primary Outcome Measures

Name	Time	Method
Post-Operative Pain	Up to 6-weeks post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes - Physical Activity	Up to 6-weeks post-operatively	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.
Patient Reported Outcomes - Global Health	Up to 6-weeks post-operatively	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.
Patient Reported Outcomes - Mobility	Up to 6-weeks post-operatively	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.
Patient Reported Outcomes - Positive Affect	Up to 6-weeks post-operatively	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.
Patient Reported Outcomes - Strength Impact	Up to 6-weeks post-operatively	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States