Mindfulness in Fracture Recovery and Reduction of Opioid Reliance (MIRROR): Evaluating the Feasibility of Implementing a Brief, Mindfulness-based Intervention to Manage Pain and Anxiety Before and After Fracture Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- McMaster University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Proportion of eligible patients who provide informed consent
Study Overview
Brief Summary
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.
Detailed Description
1.0 INTRODUCTION 1.1 Pain, Anxiety, and Opioid Use After Fracture Fracturing a bone is both physically traumatic and psychologically distressing. Anxiety is common as patients awaiting fracture surgery struggle to quickly process what has happened to them and consider the risks and uncertainties that now lie ahead. In addition to this acute psychological distress, fracture patients often suffer from severe physical pain both before and after surgical treatment. During their post-operative hospitalization, fracture patients often receive both opioid-based and neuromodulating medications to manage their pain. Patients are then discharged from the hospital with instructions for rehabilitation and a prescription for analgesic medications - most often opioids. In fact, orthopaedic surgeons prescribe more opioid medications than any other surgical specialty and North American orthopaedic surgery patients take far more opioids than patients in other parts of the world. Despite the widespread use of opioids, patients often continue to struggle with severe pain and are not more satisfied with their pain management. In the context of the current opioid epidemic, the lack of non-pharmacological interventions available to address pain in fracture patients necessitates an urgent evaluation of alternative treatment strategies that could feasibly be integrated into current care pathways.
1.2 Mindfulness-Based Interventions Randomized controlled trials (RCTs) indicate that mindfulness-based interventions (MBIs) can effectively manage pain in many populations. Unfortunately, many challenges exist when considering how to implement an MBI in-hospital shortly after a traumatic event, such as a fracture. What fracture patients need is an intervention that is brief enough to be delivered at strategic times during their hospital stay, yet comprehensive enough to teach them pain self-management strategies capable of encouraging meaningful improvement in pain during the sensitive, subacute recovery period (i.e., weeks 1-6).
1.3 Need for a Pilot Trial To successfully implement a multicentre, randomized controlled trial that would evaluate the effects of a brief, perioperative mindfulness-based intervention on pain, anxiety, and opioid use before and after fracture surgery, a pilot trial is necessary to inform the trial's design and feasibility. The proposed pilot trial will (1) determine if participant recruitment is feasible, (2) assess key aspects of the protocol including treatment allocation compliance and follow up, and (3) assess the proportion of patients who are experiencing pain at six weeks post-randomization to support the sample size calculation for a larger, definitive trial.
2.0 OBJECTIVES 2.1 Feasibility Objectives
The primary objective is to assess the design and feasibility of the trial in preparation for a definitive multi-center trial. Specifically:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The inclusion criteria are:
- •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.
Exclusion Criteria
- •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;
- •Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture;
- •Previously completed a standardized mindfulness program (e.g., MBSR) or regularly (e.g., daily) practice mindfulness;
- •Active psychosis;
- •Active suicidality;
- •Stress fracture;
- •Fragility fracture;
- •Currently enrolled in a study that does not permit co-enrolment in other trials;
- •Not willing to participate in the intervention;
- •No provision of informed consent; or
- •Other reason as approved by the Data Coordinating Centre.
Outcomes
Primary Outcomes
Proportion of eligible patients who provide informed consent
Time Frame: Through study completion, an average of 6 months
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%.
Length of time it takes to enroll 50 participants
Time Frame: Through study completion, an average of 6 months
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.
Review of reasons for exclusions
Time Frame: Through study completion, an average of 6 months
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.
Proportion of participants assigned to the treatment arm who complete both phases of the MBI
Time Frame: Through study completion, an average of 6 months
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%.
Proportion of complete data in all case report forms
Time Frame: Through study completion, an average of 6 months
To determine the feasibility of the intervention and data collection, the proportion of complete data in all case report forms will be calculated. 5% or less of data can be missing, but no more than 10%.
Proportion of participants who withdraw consent to participate
Time Frame: Through study completion, an average of 6 months
To determine the feasibility of the intervention and data collection, the proportion of participants who withdraw consent to participant will be calculated. This should be fewer than 5%, but no more than 10%.
Secondary Outcomes
- Pain, Enjoyment of Life and General Activity(For 6 weeks from the date of enrollment)
- Numeric Pain Rating Scale(For 6 weeks from the date of enrollment)
- Anxiety Visual Analogue Scale(For 6 weeks from the date of enrollment)
- Pain Catastrophizing Scale(For 6 weeks from the date of enrollment)
- Opioid Use(For 6 weeks from the date of enrollment)