Surgery Clinical Trial
— MNFOfficial title:
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
Verified date | January 2024 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: 1. Aged 10-18 years 2. English speaking 3. Ability to provide assent/consent/parent permission 4. 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: 1. Previous exposure to psychological interventions 2. Surgery within 1 year 3. Developmental delay 4. Chronic opioid use within 6 months prior to surgery 5. Severe systemic disease |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center (CCHMC) | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | The Society for Pediatric Anesthesia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Disability Index (FDI) | 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). | Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months. | |
Secondary | Child and Adolescent Mindfulness Measure (CAMM) | 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. | Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months. | |
Secondary | Child Anxiety Sensitivity Index (CASI) | 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. | Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months. | |
Secondary | Electronic Pain Diary and PainDETECT | 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. | Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months. | |
Secondary | Perioperative Opioid use | 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. | Postoperative inpatient (if applicable), 1 week, 2 weeks and 3-4 months postoperatively. | |
Secondary | PROMIS pain interference-short form | 8 items assessing how pain interferes with daily activities such as ambulating and doing school work. Total score range 8-40. | Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months. | |
Secondary | Pain Coping Efficacy | 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. | Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months |
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