Meditation for Postoperative Pain

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Paroxetine, Fluoxetine, Cimetidine, Duloxetine

Disqualifiers: Renal disease, Liver disease, Cardiac conditions, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.

Who Is on the Research Team?

Vidya Chidambaran, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am at least 8 years old.

I have been diagnosed with pectus excavatum or scoliosis.

Exclusion Criteria

I have or had kidney or liver disease.

You have a confirmed delay in your development.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants undergo preoperative assessments and, if randomized, receive focused-attention meditation training

2 weeks

1 visit (in-person)

Postoperative

Participants are monitored for pain scores, sleep quality, and psychosocial measures; meditation group continues intervention

8 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for long-term outcomes including pain and psychosocial measures

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Meditation

Trial Overview 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.

How Is the Trial Designed?

Group I: Meditation Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+