Not yet recruitingNAINTERVENTIONAL

Mindfulness in Fracture Recovery and Reduction of Opioid Reliance: Evaluating the Feasibility of Implementing a Brief, Mindfulness-based Intervention to Manage Pain and Anxiety Before and After Fracture Surgery

Breaking a bone can be very tough, causing both physical pain and a lot of worry, especially around surgery. Many people then rely on strong pain medicines, which can have serious risks. This study is exploring a new way to help. It's testing if short, guided mindfulness exercises before and after surgery for a broken arm or leg can help people feel less pain and anxiety, and possibly use fewer pain medications. Participants will listen to either mindfulness exercises or educational recordings. The main goal is to see if this approach is practical and if there are early signs it could make a difference. If successful, this simple, low-cost method could help many patients recover better.

At a glance

Status

Not yet recruiting

Phase

Sponsor

McMaster University

Enrolment target

Start

01 May 2026

Estimated completion

30 Oct 2026

Orthopaedic Fractures Orthopaedic Trauma Fractures and Non-unions Orthopaedic Trauma Orthopaedic Surgery Orthopaedic Related Pain (Musculoskeletal Pain)Anxiety Acute Anxiety After Surgery Opioid Use Opioid Use After Surgery

What is this study about?

When you break a bone, it's not just physically painful; it can also be a very upsetting and stressful experience. You might feel anxious as you get rushed to the hospital, face emergency treatment, and get ready for surgery. After the operation, many people continue to struggle with pain and often need strong pain medicines. While these medicines can be helpful, they also carry risks, including the potential for addiction. Because of these concerns, doctors are looking for new and safer ways to help people manage their pain.

This study is investigating whether mindfulness can be one of these new ways. Mindfulness is about focusing on the present moment, and it has been shown to help reduce stress and pain in other situations. People taking part in this study, who have broken an arm or leg and need surgery, will be split into two groups by chance. One group will listen to a short, guided mindfulness exercise on an audio recording before surgery to help with anxiety, and another after surgery to help manage pain. The other group will listen to a different audio recording that provides educational information, both before and after surgery.

The main purpose of this study is to find out if this approach is practical – for example, if enough people are willing to take part and if they complete the audio recordings. The study will also look for early signs to see if these exercises can help reduce pain and anxiety, and how much strong pain medicine people use, for about six weeks after surgery. If this study shows that the idea is practical and promising, a larger study can then be done to get a clearer picture of how much these exercises can help people managing pain and reduce their need for pain medications after surgery. This simple, low-cost approach could potentially be used widely in hospitals to support recovery.

Key takeaways

Exploring if mindfulness helps manage pain and anxiety after bone surgery.
Compares short audio mindfulness exercises to educational recordings.
Primary goal is to check if this approach is practical in a hospital setting.
May help reduce reliance on strong pain medications with serious risks.
If successful, could offer a simple, low-cost way to improve patient recovery.

Who may be eligible?

To join this study, you must be at least 18 years old and have broken an arm or leg that requires surgery. You might have more than one broken bone and still be able to participate. It's important that you can understand and speak English well enough for the study, and that you do not have certain conditions like head injuries, severe hearing or vision problems that would stop you from listening to the audio recordings, or severe mental health conditions like psychosis.

Also, you should not join if you are already in prison or if you have recently completed a mindfulness program or regularly practice mindfulness, as this could affect the study's results. If you have other injuries that are likely to cause more problems or take longer to heal than your broken limb, you might not be suitable. The study also cannot include people with certain types of fractures, like stress fractures or those due to very weak bones (fragility fractures).

Finally, you need to be willing to take part in the study and give your informed consent, which means you understand what's involved and agree to participate. If you're currently in another study that doesn't allow you to join other trials, you won't be able to participate in this one either.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a broken arm or leg requiring surgery?
Can you understand and speak English well enough to follow instructions?
Have you NOT regularly practiced mindfulness or completed a mindfulness program recently?
Do you NOT have a head injury or severe vision/hearing problems?
Are you willing to participate in the study recordings and provide consent?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to listen to two short audio recordings (about 7 minutes each) on an audio player. You'll listen to the first one before your surgery for your broken arm or leg, and the second one after your surgery, while you're still in the hospital. You will be randomly assigned to either listen to mindfulness exercises or an educational recording. After you leave the hospital, the study team will check in with you occasionally for about six weeks after your surgery to see how you are feeling and if the intervention helps with your pain and anxiety. There are no extra hospital visits required beyond your usual medical care, and no specific medications are being given as part of the study itself beyond what your doctors prescribe for your recovery. The total duration of active participation, including follow-up, is approximately six weeks.

Potential risks and benefits

A potential benefit of taking part in this study is that the mindfulness exercises might help you manage your pain and anxiety better, possibly reducing your need for strong pain medications after surgery. You'll also be contributing to important research that could help many future patients. As for risks, there are generally no known serious risks associated with listening to audio recordings or mindfulness practices, but some people might find it takes a little effort to concentrate or might not find it helpful for their specific pain or anxiety. You are always free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hamilton Health Sciences - Hamilton General Hospital
Verified postcode
Hamilton, Canada

Common questions

What is mindfulness?

Mindfulness is a practice that teaches you to focus on the present moment, which can help reduce stress and improve your ability to cope with pain and difficult feelings.

Will I definitely get the mindfulness exercises if I join?

No, you will be randomly assigned to one of two groups: one will listen to mindfulness exercises, and the other will listen to educational recordings. It's like flipping a coin to decide.

How long do the audio recordings last?

Each audio recording is quite short, lasting about 7 minutes.

Will this study affect my usual pain medication?

The study aims to see if mindfulness might help reduce the need for strong pain medications, but your doctors will continue to prescribe what they believe is best for your pain management during your recovery.

What kind of broken bones are included?

This study is for people who have broken an arm or leg that needs surgery. It does not include stress fractures or fractures from very weak bones.

How to find out more

Jodi Gallant, MSc

gallaj4@mcmaster.ca 905-870-0613 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.