Mindfulness Surgical Pain Outcomes
- Conditions
- SurgeryPost Surgical Pain
- Interventions
- Other: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditationOther: Conventional CareOther: Provider-directed mindfulness
- Registration Number
- NCT05838443
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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.
- Previous exposure to psychological interventions
- Surgery within 1 year
- Developmental delay
- Chronic opioid use within 6 months prior to surgery
- Severe systemic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-directed mindfulness Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation - Conventional care Conventional Care Control Comparator Provider-directed mindfulness Provider-directed mindfulness -
- Primary Outcome Measures
Name Time Method Functional Disability Index (FDI) 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 Outcome Measures
Name Time Method Child Anxiety Sensitivity Index (CASI) Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months. 18-item self-report tool designed to measure symptoms of anxiety in children and adolescents, with total scores ranging from 18-54. The CASI has demonstrated high internal consistency in both clinical and nonclinical samples (aged 8-15.8 years), good test-retest reliability and good construct validity.
Child and Adolescent Mindfulness Measure (CAMM) Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months. 10-item to assess 3 out of 4 facets of mindfulness: observing, acting with awareness and accepting without judgement. Scale is 0-40 with reverse scoring 0-4, 0 being never true, 4 being always true. Higher scores correspond to higher levels of mindfulness.
Electronic Pain Diary and PainDETECT Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months. Numerical rating pain scores of average pain intensity based on electronic pain ratings for one week, activity and sleep, using free phone application ("Manage my Pain" for Android and "Pain Diary" for iPhone users). PainDETECT assesses pain nature, with high sensitivity, specificity and positive predictive accuracy in pain conditions.
Perioperative Opioid use Postoperative inpatient (if applicable), 1 week, 2 weeks and 3-4 months postoperatively. Opioid use over 4 months (total morphine equivalent dose standardized by weight). Post-operative opioid use will be obtained from electronic medical record if patient was admitted, as well as by patient/family report.
Pain Coping Efficacy Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months Evaluate pain coping as a mediator of association of the intervention with long-term functional and pain outcomes utilizing a 3-item subsurvey from a 39-item self-report questionnaire (PHQ pain coping questionnaire) to assess pain coping strategies and pain coping efficacy in children.
PROMIS pain interference-short form Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months. 8 items assessing how pain interferes with daily activities such as ambulating and doing school work. Total score range 8-40.
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center (CCHMC)
🇺🇸Cincinnati, Ohio, United States