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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

ConditionsOrthopaedic FracturesOrthopaedic Trauma Fractures and Non-unionsOrthopaedic TraumaOrthopaedic SurgeryOrthopaedic Related Pain (Musculoskeletal Pain)Anxiety AcuteAnxiety After SurgeryOpioid UseOpioid Use After Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University

About this trial

Breaking a bone is not only physically painful but also emotionally overwhelming. Patients often experience intense pain, anxiety, and uncertainty as they are rushed to hospital, undergo emergency treatment, and prepare for surgery. After surgery, many continue to struggle with pain and rely on opioid medications, which carry serious risks including addiction. In the context of our current opioid epidemic, it's critical that alternative treatment strategies are urgently evaluated.

Mindfulness is a practice that helps people focus on the present and has been shown to reduce stress and pain in other settings. In this trial, patients with broken arms or legs who need surgery at Hamilton General Hospital will be randomly assigned to one of two groups who will listen to a two-part, audio recording before and after surgery. Those in the interventional group will engage in a 7-minute audio-guided mindfulness exercise before surgery to help reduce anxiety, and another 7-minute audio-guided mindfulness exercise after surgery to help manage pain. Those in the control group will listen to a 7-minute educational audio recording before surgery and again after surgery.

The main goal is to see if this approach is practical-can enough patients be recruited, and will they complete the audio recordings? The study will also look at early signs of whether the intervention helps reduce pain, anxiety, and opioid use six weeks after surgery. If feasible, a larger study can be conducted to determine if these exercises can help patients manage pain and reduce their need for opioids after surgery.

If successful, this simple, low-cost approach could be widely used in hospitals to support recovery and reduce reliance on pain medications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years of age or older; and

Presenting to the hospital with an open or closed appendicular fracture requiring internal fixation. Patients with multiple fractures may be included.

Disqualifiers

Does not have the English-language skills required to participate in trial interventions (in the judgement of site research personnel);

Cognitive impairment (including traumatic brain injury);

Auditory or visual impairment that would inhibit ability to receive intervention;

Current incarceration;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness Based Intervention

    Behavioral

    Two 7-minute audio-guided videos, one on breathing practices, the second on pain management

  • Educational Recording

    Behavioral

    7-minute audio educational recording that describes different strategies to cope with pain and anxiety before fracture surgery. A similar recording will also be given after surgery.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Mindfulness Based InterventionExperimental treatment 1 intervention
Group B: Educational RecordingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of eligible patients who provide informed consent

To determine the feasibility of participant enrollment, the number of eligible patients who consent to the study will be counted and a percentage generated. This percentage should be over 40% but no fewer than 30%.

Time frame
Through study completion, an average of 6 months
2

Length of time it takes to enroll 50 participants

To determine the feasibility of participant enrollment, the length of time it takes to enroll 50 participants will be counted. This should take less than 8 weeks and no more than 12 weeks.

Time frame
Through study completion, an average of 6 months
3

Review of reasons for exclusions

To determine the feasibility of participant enrollment, the reasons for exclusion from the study will be reviewed. This will be a qualitative analysis of the screening data.

Time frame
Through study completion, an average of 6 months
4

Proportion of participants assigned to the treatment arm who complete both phases of the MBI

To determine the feasibility of the intervention and data collection, the number of participants in the treatment arm who complete both phases of the MBI will be calculated. This should be greater than 90% but no fewer than 70%.

Time frame
Through study completion, an average of 6 months

Secondary outcomes

1

Pain, Enjoyment of Life and General Activity

The Pain, Enjoyment of Life and General Activity questionnaire will be used to determine if brief MBI, compared to control, reduces pain intensity/interference over 6 weeks post-randomization

Time frame
For 6 weeks from the date of enrollment
2

Numeric Pain Rating Scale

The Numeric Pain Rating Scale will be used to determine if brief MBI, compared to control, reduces acute pain over the perioperative period

Time frame
For 6 weeks from the date of enrollment
3

Anxiety Visual Analogue Scale

The Anxiety Visual Analogue Scale will be used to determine if brief MBI, compared to control, reduces acute anxiety over the perioperative period

Time frame
For 6 weeks from the date of enrollment
4

Pain Catastrophizing Scale

The Pain Catastrophizing Scale will be used to determine if brief MBI, compared to control, reduces postoperative pain catastrophizing over 6 weeks post-randomization

Time frame
For 6 weeks from the date of enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Hamilton Health Sciences Corporation

Collaborator

Source ClinicalTrials.gov
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