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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 is a NA study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 433 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04637802
The ClinicalTrials.gov registry entry for NCT04637802 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 433 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Education is the first listed.
NCT04637802 reports 0 study locations.
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.
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