Coping After Pediatric Scoliosis Surgery

NCT04063670 | Completed

• 1 other identifier: 18-26617
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Pain; Function; Pediatric; Scoliosis; Scoliosis Surgery; Spinal Fusion; Idiopathic Scoliosis; Coping; Coping Skills; Education; Video Intervention; Randomized; Prospective; Satisfaction; Adolescent; Opioid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Patient Reported Outcomes - Global Health

  Up to 6-weeks post-operatively

• Patient Reported Outcomes - Mobility

  Up to 6-weeks post-operatively

• Patient Reported Outcomes - Positive Affect

  Up to 6-weeks post-operatively

• Patient Reported Outcomes - Physical Activity

  Up to 6-weeks post-operatively

• Patient Reported Outcomes - Strength Impact

  Up to 6-weeks post-operatively

Other Outcomes (1)

• Pain-Related Disability and Post-Operative Functional Status.

  Up to 6-weeks post-operatively

Study Arms (2)

Control

ACTIVE COMPARATOR

Routine, standard-of-care treatment

Other: Control

Video Intervention

EXPERIMENTAL

Routine, standard-of-care PLUS peri-operative video series

Other: Video Intervention

Interventions

Video Intervention OTHER

Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis

Video Intervention

Control OTHER

Routine, Standard-of-Care

Control

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (5)

• Charette S, Fiola JL, Charest MC, Villeneuve E, Theroux J, Joncas J, Parent S, Le May S. Guided Imagery for Adolescent Post-spinal Fusion Pain Management: A Pilot Study. Pain Manag Nurs. 2015 Jun;16(3):211-20. doi: 10.1016/j.pmn.2014.06.004. Epub 2014 Nov 6.

  PMID: 25439116 BACKGROUND

• LaMontagne L, Hepworth JT, Salisbury MH, Cohen F. Effects of coping instruction in reducing young adolescents' pain after major spinal surgery. Orthop Nurs. 2003 Nov-Dec;22(6):398-403. doi: 10.1097/00006416-200311000-00005.

  PMID: 14705469 BACKGROUND

• Rabbitts JA, Aaron RV, Fisher E, Lang EA, Bridgwater C, Tai GG, Palermo TM. Long-Term Pain and Recovery After Major Pediatric Surgery: A Qualitative Study With Teens, Parents, and Perioperative Care Providers. J Pain. 2017 Jul;18(7):778-786. doi: 10.1016/j.jpain.2017.02.423. Epub 2017 Feb 21.

  PMID: 28232147 BACKGROUND

• Rhodes L, Nash C, Moisan A, Scott DC, Barkoh K, Warner WC Jr, Sawyer JR, Kelly DM. Does preoperative orientation and education alleviate anxiety in posterior spinal fusion patients? A prospective, randomized study. J Pediatr Orthop. 2015 Apr-May;35(3):276-9. doi: 10.1097/BPO.0000000000000260.

  PMID: 25036417 BACKGROUND

• Connelly M, Fulmer RD, Prohaska J, Anson L, Dryer L, Thomas V, Ariagno JE, Price N, Schwend R. Predictors of postoperative pain trajectories in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2014 Feb 1;39(3):E174-81. doi: 10.1097/BRS.0000000000000099.

  PMID: 24173016 BACKGROUND

MeSH Terms

Conditions

Pain; Scoliosis; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Mohammad Diab, MD

  UCSF Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: All clinicians and care providers are blinded to participants randomized group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: August 21, 2019
• Study Start: May 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)