Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

  • STATUS
    Recruiting
  • End date
    Aug 29, 2024
  • participants needed
    400
  • sponsor
    Seattle Children's Hospital
Updated on 29 January 2021

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).

Description

Major musculoskeletal surgeries are associated with particularly high prevalence of both acute and chronic post-surgical pain (CPSP), with 80% of youth reporting intense acute pain after hospital discharge, and up to half reporting CPSP up to one year after spine surgery. Interventions to improve recovery and reduce pain after surgery have potential to interrupt a negative trajectory of suffering and disability associated with chronic pain. Our specific aims are: Primary: (1) Determine effectiveness of a pre-operative mHealth psychosocial intervention to improve acute pain outcomes in adolescents undergoing major musculoskeletal surgery, (2) Determine effectiveness of a post-operative mHealth psychosocial intervention to improve chronic pain outcomes at 3 months in adolescents undergoing major musculoskeletal surgery, (3) Determine the combined effects of pre- and post-operative psychosocial intervention on chronic pain outcomes. Secondary: (1) Determine effectiveness of pre-operative psychosocial intervention to reduce opioid use during the 14 days following hospital discharge, (2) Determine effectiveness of psychosocial intervention to improve health-related quality of life following surgery.

Details
Condition Spondylolisthesis, Kyphosis, Scoliosis Idiopathic, Juvenile; Scoliosis, Scoliosis; Adolescence, Scoliosis;Congenital
Treatment Education, CBT (SurgeryPal)
Clinical Study IdentifierNCT04637802
SponsorSeattle Children's Hospital
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Teen
to 18 years old at the time of enrollment
Undergoing scheduled spinal fusion surgery (eligible indications: idiopathic scoliosis, juvenile scoliosis, spondylothesis 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)
Recent psychiatric admission (in the past 30 days)
Severe systemic disease (neuromuscular scoliosis, cancer)
Takes medication daily for treatment of a chronic medical condition (except allergies, asthma, anxiety, depression)
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)
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