Mindfulness Surgical Pain Outcomes (MNF)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Surgery; Post Surgical Pain
• Intervention / Treatment: Other: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation; Other: Provider-directed mindfulness; Other: Conventional Care

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center (CCHMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-directed mindfulness	Other: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation; Neurofeedback-assisted, technology-supported mindfulness via EEG-supported device delivered individually without the need for a facilitator or travel to training site. The device allows noninvasive neural activity recording from frontal and posterior brain regions. A dedicated smartphone application uses the EEG data to provide real-time adaptive feedback-modulating natural sounds to prompt user awareness of mind-wandering and intentional return to present experience. A smartphone app will guide patients through attention and focus on breath exercises. Patients will hear their distracted mind as the wind. Wind becomes stronger if their mind wanders, prompting patient's awareness of their wandering mind and guiding the patient back to focusing on their breath without judgment of how they are doing. Patients will be asked to practice mindfulness using the device for 20 minutes per day for 4 sessions prior to surgery.
Active Comparator: Provider-directed mindfulness	Other: Provider-directed mindfulness; Patients will receive mental health support by a licensed social work provider who is trained in mindfulness through four 20-minute telehealth sessions. Patients will be taught cognitive behavioral therapy (CBT) techniques to reduce pain catastrophizing and increase coping efficacy, the clinician will review patient's current sleep routine and teach concepts and strategies to improve sleep. Patients will be guided through mindfulness and meditation exercises to improve pain and mood coping. Mindfulness-based instructions takes patients through quieting their mind by focusing on breath, expanding focus (i.e., "at the tip of their nose" "full flow of the breath"), with emphasis on acknowledgement of arising thoughts/emotions without judgement or emotional reaction, and return attention back to breath sensation. Principles of CBT and mindfulness will be reiterated at subsequent sessions.
Other: Conventional care; Control Comparator	Other: Conventional Care; Control group, as defined by our institution's standard preoperative care for given procedure, which does not include psychological preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: The Society for Pediatric Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2022-0008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No