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Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

Study acronym: SurgeryPal
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Results posted: Sep 24, 2026 Show 9 more changesShow less
    • Lead sponsor: Seattle Children's Hospital to Seattle Children's Hospital
    • Primary endpoints revised (2)
    • Primary completion date: Dec 5, 2024 to May 21, 2025
    • Study completion date: Mar 12, 2025 to May 21, 2025
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints revised (8)
    • Site details revised
    • Collaborators: details revised at 1 of 5 entries
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Jan 31, 2025 to Dec 5, 2024
    • Study completion date changed from estimate of Apr 30, 2025 to Mar 12, 2025
    v6
  3. Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Enrollment target: estimated 500 to confirmed 433
    • Primary completion date: Aug 2025 to Jan 31, 2025
    • Study completion date: Aug 2025 to Apr 30, 2025
    • Site details revised
  4. Primary and study completion dates: Aug 2024 to Aug 2025
    • Enrollment target: 400 to 500
    • Eligibility criteria expanded, about 10 words
    v4
  5. Enrollment target: 500 to 400v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 25, 2020 to Dec 29, 2020
    • Site details revised
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).
Trial Details
NCT Number NCT04637802
Lead Sponsor Seattle Children's Hospital
Collaborators: Duke University, University of Utah, Vanderbilt University, Johns Hopkins University, Connecticut Children's Medical Center
Conditions
(from sponsor)		 Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital, Kyphosis, Spondylolisthesis
Related terms Acute Pain, Chronic Pain, Kyphosis, Scoliosis, Spondylolisthesis
Enrollment 433 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov