[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04336579":3,"trial-entities:NCT04336579":96,"trial-summary:NCT04336579":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":72,"locations":75,"central_contacts":85,"overall_officials":91,"references":94,"see_also_links":95},"NCT04336579","HS-19-00223","Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients","Diaphragmatic Breathing Exercises As An Analgesia Adjunct in Total Knee Arthroplasty Patients in the Perioperative Period","RECRUITING","2024-10-01","2024-08","2024-08-27","2024-06-10","University of Southern California","OTHER",false,"Rationale: While total knee replacements (TKA) are one of the most commonly performed surgical procedures in the United States, this procedure can also be very painful. Postoperative mobilization and rehabilitation is vital to a patient's recovery, but inadequate pain control can impede patients' progress. Diaphragmatic breathing is an additional non-pharmacological and non-invasive tool with no adverse effects that could aid in recovery. This will serve as a pilot study for a possible larger controlled trials.","Study population: Patients (participants) undergoing total knee arthroplasty at Keck USC Hospital at HC3\n\nStudy methodology: Patients (participants) will be taught with the aide of a handout and instructional videos preoperatively and in the recovery room on how to perform diaphragmatic breathing exercises for post-operative pain control. Patient (participant) pain levels will be assessed using the visual analog scale (VAS). The investigators will then be comparing VAS scores and daily opioid doses (morphine equivalents) between the study group and a control group. The control group will include prior patients (participants) over the past year who underwent TKA at Keck Hospital and also had pain scores and opioid usage measured, but did not receive the breathing treatment.\n\nStudy endpoints: Endpoints will include: pain levels via VAS scale, anxiety levels via VAS scale, and opioid usage (morphine equivalents).",[19],"Anesthesia and Analgesia",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Diaphragmatic Breathing","Simple diaphragmatic breathing exercise",[30],[34,38,41,44,47,48,50,52,53,55,57,58],{"measure":35,"description":36,"timeFrame":37},"Pain Level","Verbal Analog Pain Score - rate pain on 0-10 scale where 0=no pain, 10= worst possible pain","Prior to intervention",{"measure":39,"description":40,"timeFrame":37},"Opioid Usage (morphine equivalents)","Opioid Usage for pain",{"measure":42,"description":43,"timeFrame":37},"Anxiety Level","Verbal Analog Score -rate anxiety on 0-10 scale where 0= no anxiety, 10= worst possible anxiety",{"measure":35,"description":45,"timeFrame":46},"Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain","15 minutes after intervention",{"measure":39,"description":40,"timeFrame":46},{"measure":42,"description":49,"timeFrame":46},"Verbal Analog Score - rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety",{"measure":35,"description":45,"timeFrame":51},"6 hours after intervention",{"measure":39,"description":40,"timeFrame":51},{"measure":42,"description":54,"timeFrame":51},"Verbal Analog Score- rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety",{"measure":35,"description":45,"timeFrame":56},"1 day after intervention",{"measure":39,"description":40,"timeFrame":56},{"measure":42,"description":59,"timeFrame":56},"Verbal Analog Score - rate anxiety on 0-10 scale where 0 = no anxiety, 10 = worst possible pain",[],"ALL","50 Years","90 Years",{"inclusion":65,"exclusion":67,"raw_text":71},[66],"Patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter",[68,69,70],"Inability to perform or learn diaphragmatic breathing exercises or do not wish to participate in diaphragmatic breathing or study protocol","Pregnant patients","Patients without continuous peripheral nerve block catheter","Inclusion Criteria:\n\n* Patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter\n\nExclusion Criteria:\n\n* Inability to perform or learn diaphragmatic breathing exercises or do not wish to participate in diaphragmatic breathing or study protocol\n* Pregnant patients\n* Patients without continuous peripheral nerve block catheter",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Keck Hospital of USC","Los Angeles","California","90033","United States",{"lat":83,"lon":84},34.05223,-118.24368,[86],{"name":87,"role":88,"phone":89,"email":90},"Linda J Rever, MD","CONTACT","3234427400","rever@usc.edu",[92],{"name":87,"affiliation":13,"role":93},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Total Knee Replacement",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an observational study comparing 50 participants who learn diaphragmatic breathing to a control group of past patients. It is not a randomized controlled trial.","completed","Diaphragmatic Breathing Exercises for Total Knee Arthroplasty Patients","This observational study is looking at whether simple diaphragmatic breathing exercises can help manage pain and anxiety, and reduce the need for opioid pain medication, after total knee replacement surgery. Researchers will compare pain levels, anxiety levels, and opioid use in patients who learn and perform these breathing exercises to a group of past patients who did not. You may be able to join if you are between 50 and 90 years old, are having a total knee replacement, and will have a continuous peripheral nerve block catheter (a type of pain relief). This study is currently unclear on its recruitment status and aims to enroll 50 participants.","Pain, opioid usage, and anxiety levels are measured prior to intervention, but the duration of follow-up after intervention is not specified.",108,"You will be taught how to perform diaphragmatic breathing exercises using a handout and videos before and after surgery. Your pain and opioid use will be measured.","Not stated in the trial record.",[30],"v2"]