Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT04637802
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT04637802
Study Brief:
Protocol Section:
NCT04637802