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Mindfulness Surgical Pain Outcomes (MNF)

Primary Purpose

Postsurgical Pain Outcomes After Major Musculoskeletal Surgeries Associated With High Risk of Chronic Postsurgical Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation
Provider-directed mindfulness
Conventional Care
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postsurgical Pain Outcomes After Major Musculoskeletal Surgeries Associated With High Risk of Chronic Postsurgical Pain

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center (CCHMC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Self-directed mindfulness

Provider-directed mindfulness

Conventional care

Arm Description

Control Comparator

Outcomes

Primary Outcome Measures

Functional Disability Index (FDI)
15-item scale 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

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.
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.
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 smartphone 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
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.
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.
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 subscale from a 39-item self-report questionnaire (PHQ pain coping questionnaire) to assess pain coping strategies and pain coping efficacy in children.

Full Information

First Posted
April 19, 2023
Last Updated
April 19, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
The Society for Pediatric Anesthesia
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1. Study Identification

Unique Protocol Identification Number
NCT05838443
Brief Title
Mindfulness Surgical Pain Outcomes
Acronym
MNF
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
The Society for Pediatric Anesthesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain Outcomes After Major Musculoskeletal Surgeries Associated With High Risk of Chronic Postsurgical Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-directed mindfulness
Arm Type
Active Comparator
Arm Title
Provider-directed mindfulness
Arm Type
Active Comparator
Arm Title
Conventional care
Arm Type
Other
Arm Description
Control Comparator
Intervention Type
Other
Intervention Name(s)
Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Provider-directed mindfulness
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Care
Intervention Description
Control group, as defined by our institution's standard preoperative care for given procedure, which does not include psychological preparation.
Primary Outcome Measure Information:
Title
Functional Disability Index (FDI)
Description
15-item scale 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).
Time Frame
Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Secondary Outcome Measure Information:
Title
Child and Adolescent Mindfulness Measure (CAMM)
Description
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.
Time Frame
Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Title
Child Anxiety Sensitivity Index (CASI)
Description
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.
Time Frame
Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Title
Electronic Pain Diary and PainDETECT
Description
Numerical rating pain scores of average pain intensity based on electronic pain ratings for one week, activity and sleep, using free smartphone 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.
Time Frame
Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Title
Perioperative Opioid use
Description
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.
Time Frame
Postoperative inpatient (if applicable), 1 week, 2 weeks and 3-4 months postoperatively.
Title
PROMIS pain interference-short form
Description
8 items assessing how pain interferes with daily activities such as ambulating and doing school work. Total score range 8-40.
Time Frame
Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
Title
Pain Coping Efficacy
Description
Evaluate pain coping as a mediator of association of the intervention with long-term functional and pain outcomes utilizing a 3-item subscale from a 39-item self-report questionnaire (PHQ pain coping questionnaire) to assess pain coping strategies and pain coping efficacy in children.
Time Frame
Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl Hartzell, MD
Phone
(513) 636-4408
Email
Cheryl.Hartzell@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Rajvi Parikh, MHA
Phone
513-803-0004
Email
Rajvi.Parikh@cchmc.org
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center (CCHMC)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Hartzell, MD
Phone
513-636-4408
First Name & Middle Initial & Last Name & Degree
Cheryl Hartzell, MD

12. IPD Sharing Statement

Learn more about this trial

Mindfulness Surgical Pain Outcomes

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