Coping After Pediatric Scoliosis Surgery

Study Purpose

This is a prospective, randomized controlled trial evaluating the efficacy of expanded patient education and coping skills on pain management following multilevel pediatric spinal surgery. The intervention will include a smartphone- based platform and a comprehensive library of peri-operative educational and coping skills videos as a means for better addressing the psychosocial elements of a child's individual pain experience. The study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	11 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion criteria:

- All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach.

Exclusion Criteria:

- Non-English speaking.

- Non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic.

- Other comorbidity, including developmental delay.

- Any surgical complication that results in significant divergence from our institution's standard scoliosis pathway.

- Unplanned admission within 6 weeks of index operation.

- Active treatment psychotherapy and/or cognitive behavioral therapy for any reason

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04063670
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, San Francisco
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mohammad Diab, MDAlex Gornitzky, MD
Principal Investigator Affiliation	UCSF Department of Orthopaedic SurgeryUCSF Department of Orthopaedic Surgery
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adolescent Idiopathic Scoliosis

Arms & Interventions

Arms

Active Comparator: Control

Routine, standard-of-care treatment

Experimental: Video Intervention

Routine, standard-of-care PLUS peri-operative video series

Interventions

Other: - Video Intervention

Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis

Other: - Control

Routine, Standard-of-Care

Contact a Trial Team

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University of California, San Francisco, San Francisco, California

Status

Address

University of California, San Francisco

San Francisco, California, 94158

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