Juvenile; ScoliosisSurgeryPalNCT04637802
Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
A study testing CBT (SurgeryPal) and Education in people with Juvenile; Scoliosis and Scoliosis Idiopathic, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence
- What is being tested?
- CBT (SurgeryPal) and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2020to 21 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Effectiveness of an mHealth Psychosocial Intervention to Prevent Transition From Acute to Chronic Postsurgical Pain in Adolescents
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).
Read the detailed 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.
- Conditions
- Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital, Kyphosis, Spondylolisthesis
- Being tested
- CBT (SurgeryPal), Education
- Keywords
- Psychosocial Intervention, Spinal Fusion Surgery, Chronic Pain, Acute Pain, Adolescent, Randomized controlled trial
- Medical subject headings
- Scoliosis, Kyphosis, Spondylolisthesis, Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT (SurgeryPal)Behavioural
The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.
EducationBehavioural
The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative and Post-operative Education intervention | Active comparator | This arm receives access to Patient Education intervention in the pre- and post-operative phases. Receives: Behavioral: Education |
| Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention | Experimental | This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase. Receives: Behavioral: CBT (SurgeryPal); Behavioral: Education |
| Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal) | Experimental | This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period. Receives: Behavioral: CBT (SurgeryPal); Behavioral: Education |
| Pre-operative and Post-operative CBT intervention (SurgeryPal) | Experimental | This arm receives access to CBT intervention during the pre-operative and post-operative period. Receives: Behavioral: CBT (SurgeryPal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical Pain Severity and Interference
The Brief Pain Inventory (BPI) has 2 scales: pain severity (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 severity or interference (worse). The 24 hour (short) version of this measure will be completed via REDCap daily for 14 days post-discharge (beginning on day 1 after hospital discharge, and ending on day 14, up to a maximum of 3-weeks post-surgery). Daily scores from days 1-14 post-hospital-discharge were averaged for each participant, and mean values across all participants are reported here.
Measured: 1-14 days post-hospital-discharge, up to 3 weeks post-surgery (T2)
Chronic Pain Severity and Interference
The Brief Pain Inventory (BPI) has 2 scales: pain severity (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 severity or interference (worse). The 24 hour (short) version of this measure will be completed via REDCap daily for 7 days at 3 months after the participant's surgery date. Daily scores across the 7 days were averaged for each participant, and mean values across all participants are reported here.
Measured: 3 months post-surgery (T3)
Secondary outcomes (8)
Change in Health-related Quality of Life
The Pediatric Quality of Life Inventory (Peds-QL) 15-item short form assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used and demonstrates good reliability for both the parent and child self-report measures. Scale scores (all scales, including both total and subscales) range from 0 to 100. Higher scores indicate fewer difficulties (better) health-related quality of life. Subscales of physical and psychosocial health will be used in analyses.
Measured: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Opioid Use
Youth will report medication use on the Brief Pain Inventory (BPI), including selecting medication name from a dropdown list (opioid, acetaminophen, anti-inflammatory, other). Number of days of opioid use will be used in analyses.
Measured: Up to 3 weeks post-surgery (T2), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Opioid Misuse
The American Psychiatric Association (APA) Adapted National Institute for Drug Abuse (NIDA) Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Level 2 Tool (Teen Report) recommended by the National Institute on Drug Abuse for substance use screening in adolescents, will be used to assess opioid misuse. Additional questions on reasons for misuse (e.g. to treat pain, to get high, etc.) and source of opioids (e.g. prescription, from a friend or relative) will be collected using the corresponding questions and response options used in the National Survey on Drug Use and Health. For analysis, we will report the percentage of participants that endorsed any opioid misuse at each assessment.
Measured: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Psychosocial Distress
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms that evaluates negative mood, view of self and social cognitions. Response options range from 1 (Never) to 5 (Almost Always). Raw scores for anxiety and depression are obtained by summing the corresponding items' response values, and range from 8 to 40 with higher scores indicating higher distress. Raw scores and T-scores are computed with higher T-scores above 60 indicating clinically elevated (worse) symptoms. The general population mean T-score is 50, with a standard deviation of 10. Anxiety T-scores range from 33.5-83.3, and depression T-scores range from 35.2-82.4. T-scores are reported here.
Measured: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Mental Health
Parents and teens will self-report on the Patient Health Questionnaire-4, a 4 item screening measure of general anxiety and depressive symptoms. Response options range from 0 (Not at all) to 3 (Nearly Every Day). Total scores are calculated by summing items, for a total score ranging from 0 to 12, with higher scores indicating greater anxiety and depressive symptoms (poorer outcome).
Measured: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Sleep Quality
The Adolescent Sleep Wake Scale 10-item version (Teen Report) is a 10-item measure that assesses self-reported sleep quality. Scale scores (including both individual/subscale and total scores) range from 1 to 6 with higher scores indicating better sleep quality. The total score reported here is the average of all subscale scores.
Measured: Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Pain Catastrophizing
The Pain Catastrophizing Scale - Child Version and Parent Version is a Self-report 13 item measures that assess child pain catastrophizing and parent's catastrophizing about child's pain, respectively. Total scores range from 0 to 52 with higher scores indicating greater pain catastrophizing (worse).
Measured: Baseline (T1), 3-months post-surgery (T3)
Global Pain Severity
The Patient Global Impression of Severity Scale (PGIS), Teen Report is a 1-item measure that assesses adolescent's self-reported global impression of pain severity. Response options range from 0 (none) to 3 (severe) with higher scores indicating higher pain severity (worse).
Measured: Up to 3 weeks post-surgery (T2), 3-months post-surgery (T3), 6-months post-surgery (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start29 Dec 2020
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile; ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized and double-blinded controlled trial of cognitive-behavioral intervention vs education at two phases (pre-operative and post-operative)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of Utah, Vanderbilt University, Johns Hopkins University, Connecticut Children's Medical Center
- Responsible party
- Principal investigator, Jennifer Rabbitts, MBChB, Seattle Children's Hospital
- Investigators
- Jennifer Rabbitts, MD, Principal investigator, Seattle Children's HospitalTonya Palermo, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637802
- Sponsor's protocol ID
- UH3HD102038
- Acronym
- SurgeryPal
- Status last verified
- Aug 2026
- First submitted
- 6 Nov 2020
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A releasable database for underlying primary data for publications will be made broadly available on the NIH HEAL Initiative central data repository. The database will be produced and will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. In accordance with policies of the NIH, the DCC will send the releasable database to the entity determined by the NIH or specific institute to be the repository for data created under the HEAL initiative. The DCC is able to produce a relational database export, or use SAS or SPSS data sets. The DCC will accompany the database with full documentation so that individual investigators will be able to effectively use the data.
Publications
Rabbitts JA, Zhou C, de la Vega R, Aalfs H, Murray CB, Palermo TM. A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial. Trials. 2021 Jul 30;22(1):506. doi: 10.1186/s13063-021-05421-3.
PubMed 34330321