Mindfulness Surgical Pain Outcomes

NCT05838443 | Completed

• 1 other identifier: 2022-0008
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Surgical Pain; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Child and Adolescent Mindfulness Measure (CAMM)

  Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.

• Child Anxiety Sensitivity Index (CASI)

  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.

• PROMIS pain interference-short form

  Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.

Study Arms (3)

Self-directed mindfulness

ACTIVE COMPARATOR

Other: Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation

Provider-directed mindfulness

ACTIVE COMPARATOR

Other: Provider-directed mindfulness

Conventional care

OTHER

Control Comparator

Other: Conventional Care

Interventions

Self-directed mindfulness utilizing a multi-sensor EEG-supported device with neurofeedback-assisted and technology-supported meditation OTHER

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.

Self-directed mindfulness

Provider-directed mindfulness OTHER

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.

Provider-directed mindfulness

Conventional Care OTHER

Control group, as defined by our institution's standard preoperative care for given procedure, which does not include psychological preparation.

Conventional care

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Previous exposure to psychological interventions
• Surgery within 1 year
• Developmental delay
• Chronic opioid use within 6 months prior to surgery
• Severe systemic disease

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• The Society for Pediatric Anesthesia: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: January 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: July 10, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

US (1)