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NCT04637802 · ClinicalTrials.gov registry record · NA
Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
A NA study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 433
- Enrollment target
NCT04637802: Completed NA study, sponsored by Seattle Children's Hospital.
NCT04637802 is a NA study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 433 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04637802, a NA study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 433 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The Brief Pain Inventory (BPI) has 2 scales: pain intensity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 14 days post-hospital discharge (beginning on day 1 after hospital discharge, and ending up to 3-weeks post-surgery).
Interventions
- BEHAVIORAL Education
- BEHAVIORAL CBT (SurgeryPal)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2020-12-29 |
| Est. Completion | 2025-03-12 |
| Phase | NA |
What the finished NCT04637802 record still lists
NCT04637802 is an interventional study that assigns participants to a tested intervention. The registered 433 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Education is the first listed.
NCT04637802 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04637802 about?
NCT04637802 is a clinical study titled "Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery". 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 Surger...
What is the current status of trial NCT04637802?
This trial is currently completed. It is a NA study. The enrollment target is 433 participants. The study started on 2020-12-29. Estimated completion is 2025-03-12.
What interventions are being tested in trial NCT04637802?
The interventions under investigation include: Education (BEHAVIORAL), CBT (SurgeryPal) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04637802?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04637802's enrollment target sits among peer trials
433 235th of 2000 higher than 1,766 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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