Meditation for Postoperative Pain

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how meditation can help manage pain after surgery. Participants will use focused-attention meditation to potentially ease discomfort and improve recovery after procedures like pectus excavatum repair. Eligible participants include individuals aged 8 years and older, diagnosed with pectus excavatum or adolescent idiopathic scoliosis, and scheduled for the specified surgeries. By comparing meditation to standard care, researchers aim to determine if meditation can reduce pain and improve healing outcomes. As an unphased trial, this study offers a unique opportunity to explore innovative pain management techniques that could enhance recovery.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you can only take up to two medications that affect CYP2D6 activity, like paroxetine or fluoxetine.

What prior data suggests that meditation is safe for postoperative pain management?

Research has shown that mindfulness practices, such as meditation, are generally safe. Studies have found that these practices can improve mental health and reduce stress levels. Notably, these studies have reported no major safety issues, indicating that meditation is usually safe and well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about using meditation for postoperative pain because it offers a non-drug alternative to pain management, which can help reduce reliance on medications like opioids that have significant side effects and addiction risks. This approach focuses on enhancing mindfulness and self-regulation by teaching participants to maintain moment-to-moment awareness of their sensations and emotions. The use of the MUSETM headband adds a modern twist, providing real-time feedback to guide meditation practice, potentially making it more effective and accessible for managing stress and pain.

What evidence suggests that meditation might be an effective treatment for postoperative pain?

Research shows that meditation can help manage pain after surgery. Several studies have found that mindfulness-based meditation reduces pain and anxiety following surgery. For example, five out of eight studies reported better pain outcomes with meditation. One study found that these mindfulness techniques not only eased pain but also improved physical recovery after surgery. In this trial, participants in the meditation group will receive focused-attention meditation training to assess its effectiveness in aiding recovery and managing pain for surgery patients.23678

Who Is on the Research Team?

VC

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.
See 7 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: MeditationExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Citations

Meditation for perioperative pain and anxiety: A systematic ...Five of the eight RCTs reported favorable outcomes on postoperative pain after various meditation interventions. ... Mindfulness‐based meditations ...
Improving Postoperative Care Through Mindfulness-Based ...MBI was shown to positively impact both pain relief and physical functioning, while IET positively impacted physical functioning.
Effects of mindfulness-based preoperative intervention for ...Our findings suggest preoperative mindfulness-based interventions can effectively manage preoperative anxiety and postoperative pain in patients scheduled for ...
Effects of Mobile-based Mindfulness Intervention to ...Mindfulness-based interventions (MBIs) have demonstrated efficacy in improving various clinical outcomes especially in reducing stress and anxiety. Mindfulness- ...
Mindfulness Training for Postoperative PainThe primary outcome will be pain scores measured on postoperative day one. Secondary outcomes will include quality of recovery scores and perceived stress ...
Mindfulness-Based Interventions for the Reduction of ...The aim of this systematic review and meta-analysis is to evaluate the effect of mindfulness-based interventions (MBIs) on post-surgical pain in patients ...
Mindfulness-based intervention for non-farmacological ...MBIs are associated with a significant reduction in postoperative pain following THA and TKA, representing a viable non-pharmacological option for pain ...
The Association Between Mindfulness and Postoperative ...In summary, higher mindfulness was associated with lower postoperative pain in this cohort of gynecologic oncology patients. Further research is ...
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