Coping After Pediatric Scoliosis Surgery

NCT ID: NCT04063670

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-08-01

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.

Detailed Description

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Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, Randomized Controlled Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
All clinicians and care providers are blinded to participants randomized group

Study Groups

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Control

Routine, standard-of-care treatment

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Routine, Standard-of-Care

Video Intervention

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

Group Type EXPERIMENTAL

Video Intervention

Intervention Type OTHER

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

Interventions

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Video Intervention

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

Intervention Type OTHER

Control

Routine, Standard-of-Care

Intervention Type OTHER

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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Diab, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Department of Orthopaedic Surgery

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25439116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14705469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28232147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25036417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24173016 (View on PubMed)

Other Identifiers

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18-26617

Identifier Type: -

Identifier Source: org_study_id

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