Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
CompletedNot applicableNCT04637802
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Effectiveness of an mHealth Psychosocial Intervention to Prevent Transition From Acute to Chronic Postsurgical Pain in Adolescents
- Conditions
- Juvenile
- Scoliosis
- Scoliosis Idiopathic
- Scoliosis
- Adolescence
- Scoliosis
- Congenital
- Kyphosis
- Spondylolisthesis
- Interventions
- Behavioral: CBT (SurgeryPal)
- Behavioral: Education
- Sponsor
- Seattle Children's Hospital
- Collaborators
- Duke University; University of Utah; Vanderbilt University; Johns Hopkins University; Connecticut Children's Medical Center
- Start date
- 2020-12-29
- Primary completion
- 2025-05-21
- Sex
- All
- Age range
- from 12 Years to 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Teen * 12 to 18 years old at the time of enrollment * Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis) Parent/Caregiver * Parent or legal guardian of child who meets study criteria Exclusion Criteria: Teen * Does not speak or understand English * Has severe learning disability, cognitive impairment or intellectual delay (i.e. unable to read at 5th grade level) * Does not have access to a smart device (smartphone, iPad or tablet; Teens can borrow an iPad from the study team if one is available) * Recent psychiatric admission (in the past 30 days) * Severe systemic disease (neuromuscular scoliosis, cancer) * On a regular treatment regimen for a severe chronic medical condition * Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery) * Diagnosed chronic musculoskeletal pain condition (e.g. complex regional pain syndrome, fibromyalgia, widespread musculoskeletal pain) Parent/Caregiver * Does not speak or understand English * Does not have access to a smart device (smartphone, iPad or tablet)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04637802