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Meditation for Postoperative Pain

N/A

Waitlist Available

Led By Vidya Chidambaran, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for endoscopic pectus excavatum repair or spine fusion

Diagnosis of pectus excavatum or adolescent idiopathic scoliosis

Must not have

Non-English speaking

History of or active renal or liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how different genes, epigenetics, social and behavioral factors, and biology affect a person's experience of pain after surgery to repair pectus excavatum, a condition where the breastbone is sunken in.

Who is the study for?

This trial is for children from age 8 and adults with pectus excavatum or adolescent idiopathic scoliosis, who are scheduled for specific chest or spine surgeries. It's not open to those with developmental delays, serious heart, kidney, liver conditions, severe respiratory issues, recent major surgery using opioids, seizures treated with medication within the last year, certain medication use affecting CYP2D6 enzyme activity.

What is being tested?

The study aims to understand how genetics and other factors like behavior influence pain perception after chest (pectus) or spine surgery. Participants will practice meditation as a part of their postoperative care to see if it affects pain levels and recovery outcomes.

What are the potential side effects?

Since this trial involves meditation as an intervention rather than medication or invasive procedures, side effects are minimal but may include discomfort due to sitting still for long periods during meditation sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to correct a sunken chest or to fuse spine bones.

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I have been diagnosed with pectus excavatum or scoliosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I have or had kidney or liver disease.

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I do not have severe breathing issues like sleep apnea or lung fibrosis.

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I am on two or fewer medications that affect CYP2D6 activity.

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I have had major surgery that needed strong painkillers in the past 5 years.

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My BMI is over 35.

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I will need help breathing after surgery or a heart bypass machine ready during surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks

Changes in heart rate variability

Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery)

+4 more

Secondary study objectives

Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MeditationExperimental Treatment1 Intervention

Participants randomized to receive focused-attention meditation training will attend a preoperative training session, provided by a licensed/certified Holistic Health Specialist. The content will include an age appropriate explanation of focused-attention meditation, using breath as the focus; set-up and utilization of the MUSETM headband; and experiential practices. The goal of the intervention is to increase mindfulness (i.e., moment-to-moment, non-judgmental and non-reactive awareness of sensations, emotions, and thoughts), provide self-regulation strategies, and promote healthy and adaptive responses to stress.

Group II: ControlActive Control1 Intervention

Participants in the control group will receive present standard of care, which includes an assessment of participant/family needs by integrative care after surgery, as well as standard holistic health care by a licensed/certified holistic health specialist. They will not receive the MUSETM focused-attention meditation training or intervention protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meditation

2021

Completed Phase 3

~2940

0 / 9Eligibility criteria met