NCT05838443

Mindfulness Surgical Pain Outcomes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-03-31
• Completion: 2024-07-10
• First posted: 2023-05-01
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States