Pragmatic Randomized Controlled Trial Evaluating Efficacy of Presurgical Provider-directed Behavioral and Self-directed Mindfulness Interventions in Pediatric Patients Undergoing Major Elective Surgical Procedures on Postoperative Pain Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Functional Disability Index (FDI)
Study Overview
Brief Summary
This will be a prospective randomized study to evaluate novel, clinically feasible, easily deliverable, pragmatic ways of preemptively modifying known CPSP and behavioral risk factors for acute to chronic pain transitions in adolescents before surgery. In addition, it will provide mechanistic insights and build a strong foundation for future large scale interventional studies that can impact outcomes positively in children undergoing surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 10-18 years
- •English speaking
- •Ability to provide assent/consent/parent permission
- •Scheduled to undergo elective major musculoskeletal surgeries including spine fusion (idiopathic scoliosis only), abdominal surgeries, thoracic surgery including pectus repair, and major orthopedic joint surgeries.
Exclusion Criteria
- •Previous exposure to psychological interventions
- •Surgery within 1 year
- •Developmental delay
- •Chronic opioid use within 6 months prior to surgery
- •Severe systemic disease
Arms & Interventions
Conventional care
Control Comparator
Intervention: Conventional Care (Other)
Provider-directed mindfulness
Intervention: Provider-directed mindfulness (Other)
Self-directed mindfulness
Intervention: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation (Other)
Outcomes
Primary Outcomes
Functional Disability Index (FDI)
Time Frame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months.
15-item survey that assesses the extent to which children experience difficulties in completing specific tasks (for example, walking to the bathroom, eating regular meals, and being at school all day).
Secondary Outcomes
- Child Anxiety Sensitivity Index (CASI)(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.)
- Child and Adolescent Mindfulness Measure (CAMM)(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.)
- Electronic Pain Diary and PainDETECT(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.)
- Perioperative Opioid use(Postoperative inpatient (if applicable), 1 week, 2 weeks and 3-4 months postoperatively.)
- Pain Coping Efficacy(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months)
- PROMIS pain interference-short form(Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.)