[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630348":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":85,"overallStatus":92,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mindfulness Based Intervention","EXPERIMENTAL","Participants will be provided with an iPad and headphones to listen to a 7-minute, audio-guided mindful breathing exercise while waiting for surgery.\n\nDuring their post-operative hospital stay, participants will once again be provided with an iPad and headphones to listen to another 7-minute, audio-guided mindfulness practice focused on pain management.",[13],"Behavioral: Mindfulness Based Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Educational Recording","SHAM_COMPARATOR","Participants will be provided with an iPad and headphones to listen to a time-matched audio recording before surgery, and then again after surgery.",[19],"Behavioral: Educational Recording",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Two 7-minute audio-guided videos, one on breathing practices, the second on pain management",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"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.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Jodi Gallant, MSc","CONTACT","905-870-0613","gallaj4@mcmaster.ca",[36],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hamilton Health Sciences - Hamilton General Hospital","Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-79.84963,43.25011,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":33,"phoneExt":25,"email":52},"Kaitlyn Pusztai, HBSc","pusztake@mcmaster.ca",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[56],{"name":57,"class":6},"Hamilton Health Sciences Corporation","100630348","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-100630348",false,"NCT07486505","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","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","MIRROR","The inclusion criteria are:\n\n1. Adults 18 years of age or older; and\n2. Presenting to the hospital with an open or closed appendicular fracture requiring internal fixation. Patients with multiple fractures may be included.\n\nThe exclusion criteria are:\n\n1. Does not have the English-language skills required to participate in trial interventions (in the judgement of site research personnel);\n2. Cognitive impairment (including traumatic brain injury);\n3. Auditory or visual impairment that would inhibit ability to receive intervention;\n4. Current incarceration;\n5. 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;\n6. Previously completed a standardized mindfulness program (e.g., MBSR) or regularly (e.g., daily) practice mindfulness;\n7. Active psychosis;\n8. Active suicidality;\n9. Stress fracture;\n10. Fragility fracture;\n11. Currently enrolled in a study that does not permit co-enrolment in other trials;\n12. Not willing to participate in the intervention;\n13. No provision of informed consent; or\n14. Other reason as approved by the Data Coordinating Centre.","ALL","18 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[73],"NA","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.\n\nMindfulness 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.\n\nThe 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.\n\nIf successful, this simple, low-cost approach could be widely used in hospitals to support recovery and reduce reliance on pain medications.",[76,77,78,79,80,81,82,83,84],"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",[86,87,88,89,90,91],"fractures","mindfulness","pain management","fracture surgery","opioid use","anxiety","NOT_YET_RECRUITING","2026-04-06",{"date":95,"type":96},"2026-04-07","ACTUAL",{"date":98,"type":70},"2026-05-01",{"date":100,"type":70},"2026-10-30",{"name":5,"class":6},1]