Mindfulness for Broken Bones

(MIRROR Trial)

JG
Overseen ByJodi Gallant, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness exercises can help individuals with broken arms or legs manage pain and anxiety during surgery. Participants will listen to short audio recordings before and after surgery. One group will engage in mindfulness exercises (Mindfulness Based Intervention), while the other will listen to educational content. Researchers aim to determine if this approach can reduce the need for opioid pain medications. The trial seeks participants who require surgery for a broken arm or leg at Hamilton General Hospital. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management strategies without the constraints of traditional clinical trial phases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using mindfulness exercises to help manage pain and anxiety.

What prior data suggests that this mindfulness-based intervention is safe for patients with broken bones?

Research has shown that mindfulness practices are generally safe and well-tolerated by most people. Studies have found that mindfulness can reduce stress and improve mental health without causing serious side effects. In previous research, individuals using mindfulness techniques demonstrated better control over anxiety and pain, which is promising for those recovering from surgery.

Mindfulness has been used successfully in many situations and is known to have a calming effect. It helps individuals focus better and manage stress, which can be especially helpful when dealing with the pain and anxiety of a broken bone. Importantly, mindfulness does not involve medication, so there is no risk of drug-related side effects or addiction.

In summary, mindfulness practices are widely considered safe and could be a helpful addition to traditional treatment for managing pain and anxiety after surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Based Intervention for broken bones because it offers a non-pharmacological approach to pain management, unlike standard treatments such as pain medications and physical therapy. This intervention uses a 7-minute, audio-guided mindful breathing exercise to help patients manage pain both before and after surgery. By focusing on mindfulness, this method could reduce the reliance on pain medications, which often come with side effects and risk of dependency. The simplicity and accessibility of using an iPad and headphones make it an innovative addition to standard care practices, potentially enhancing recovery experiences for patients.

What evidence suggests that this mindfulness-based intervention is effective for managing pain and anxiety in patients with broken bones?

Research has shown that mindfulness practices can help reduce pain and anxiety. Studies have found that these techniques also assist with stress, depression, and addiction. Mindfulness can alter how the brain perceives pain, making it seem less intense. People who practice mindfulness often feel calmer and more in control of their emotions. This trial will compare a Mindfulness-Based Intervention with an Educational Recording. Participants may receive the Mindfulness-Based Intervention, which involves audio-guided mindfulness practices focused on pain management. This method has proven effective in various situations, suggesting it might also aid those recovering from surgery. Overall, mindfulness could be a useful way to manage pain and reduce the need for painkillers like opioids.46789

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who come to the hospital with a broken arm or leg that needs surgery. People with more than one fracture can also join.

Inclusion Criteria

This criterion is incomplete and cannot be summarized.
I am 18 years old or older.
I have a broken arm or leg that needs surgery to fix it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pre-Surgery Intervention

Participants in the MBI treatment arm will listen to a 7-minute, audio-guided mindful breathing practice while waiting for surgery

1 day
1 visit (in-person)

Post-Surgery Intervention

Participants will listen to a 7-minute, audio-guided mindfulness practice focused on pain management during their post-operative hospital stay

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness Based Intervention

Trial Overview

The study compares two groups: one listens to short mindfulness exercises before and after surgery, while the other listens to educational recordings. The goal is to see if using these audio guides helps reduce pain, anxiety, and opioid use during recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Mindfulness Based InterventionExperimental Treatment1 Intervention
Group II: Educational RecordingPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Hamilton Health Sciences Corporation

Collaborator

Trials
380
Recruited
345,000+

Citations

Mindfulness-based interventions: an overall review - PMC

MBIs are effective for improving many biopsychosocial conditions, including depression, anxiety, stress, insomnia, addiction, psychosis, pain, ...

Effectiveness of mindfulness-based interventions on the well ...

Data from the meta-analysis suggest that mindfulness interventions are effective in the short term for improving wellness in doctors, nurses and ...

Exploring the sustained impact of the Mindfulness-Based ...

Research on MBSR has demonstrated promising results in promoting wellbeing and reducing psychological distress (Frank et al., 2015; Ghawadra et ...

Critical Review: Does mindfulness intervention improve ...

Overall, results suggest that mindfulness intervention may improve the quality of life and/or depression symptoms of individuals with traumatic brain injury, ...

(PDF) Mindfulness-based approaches: A guide

approximately 80 per cent mindfulness meditation training and 20 per cent cognitive techniques. MBCT is cited in the NICE Guidance as ...

The Effectiveness of a Mindfulness-Based Intervention ... - PMC

These findings indicate that outcomes after lumbar surgery will not improve without a comprehensive strategy for better pain management that prepares patients ...

Comparing Mindfulness-based Breath Training and Heart ...

This randomized study aims to determine the effectiveness of three different types of bio-psychosocial support to pre-operative shoulder surgery ...

Mindfulness for Broken Bones · Info for Participants

Breaking a bone is not only physically painful but also emotionally overwhelming. Patients often experience intense pain, anxiety, ...

Impact of the mindfulness-based blood pressure reduction ...

Mindfulness-based interventions may improve cardiovascular health (CVH) by supporting behavioral change across multiple risk factors.