[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07227181":3,"trial-entities:NCT07227181":127,"trial-summary:NCT07227181":132},{"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":26,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":49,"secondary_outcomes":75,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":94,"locations":98,"central_contacts":117,"overall_officials":121,"references":125,"see_also_links":126},"NCT07227181","104486","Animal Assisted Therapy","Effects of Animal-Assisted Therapy on Trauma Patient's Willingness to Participate in Ambulation","RECRUITING","2026-12","2026-07","2026-07-24","2025-07-23","Andrew Bernard","OTHER",false,"This study looks at whether walking with a therapy dog helps adult and pediatric trauma patients move more during their hospital stay. Early movement after an injury or surgery can prevent problems such as blood clots, pressure sores, and muscle loss, but pain and anxiety often make it hard for patients to get out of bed.\n\nEach patient in this study takes part in two walking sessions-one with a certified therapy dog and one without a dog. The order is randomized, so some patients walk with the dog first and others walk without the dog first. Before and after each walk, patients fill out short surveys about their pain, anxiety, and motivation to move. The research team measures how far and how long each patient walks in both sessions.\n\nThe goal of this project is to see if therapy dog visits can safely and effectively improve mobility, reduce pain and anxiety, and make walking more enjoyable for trauma patients. Findings from this study may help hospitals design better rehabilitation programs that use animal-assisted therapy to support physical and emotional recovery.","Early mobilization after traumatic injury is a key component of recovery and is associated with reduced complications, shorter hospital stays, and improved functional outcomes. However, trauma patients frequently experience significant barriers to early ambulation, including pain, anxiety, fatigue, and psychological distress following injury and surgery. Animal-assisted interventions (AAI) have demonstrated benefits in reducing pain and anxiety, enhancing mood, and improving patient motivation in various hospital settings. Despite these findings, limited research has examined the role of therapy dogs in promoting early mobility specifically among adult trauma inpatients.\n\nThis randomized crossover trial investigates the effect of animal-assisted ambulation on walking duration, distance, and patient-reported outcomes among adult trauma patients admitted to an academic Level I trauma center. Each enrolled participant completes two ambulation sessions within their hospital stay: one with the presence of a certified therapy dog and handler, and one without a dog (standard physical therapy or nursing-led walk). The order of sessions is randomized to control for order effects, and all participants serve as their own control.\n\nDuring each session, objective ambulation data-including walking duration (minutes), and assistance level-are recorded by the research team or physical therapy staff. Pre- and post-session self-report measures assess pain (DVPRS), Wong-Baker Faces scale (peds), anxiety (Modified GAD-7), and motivation to mobilize (Likert scale).\n\nThe study aims to evaluate whether therapy dog-assisted ambulation results in greater walking duration and distance, as well as reduced perceived pain and anxiety, compared to standard ambulation without a therapy dog. Secondary analyses will explore potential moderating effects of time of day, patient demographics, and mechanism of injury on intervention effectiveness.\n\nAll therapy dogs and handlers are registered through a national certification organization and follow strict infection control and safety protocols consistent with institutional policy. Data will be analyzed using mixed-effects models to account for within-subject correlations and to assess crossover effects.\n\nThis study is designed to inform evidence-based integration of animal-assisted therapy into trauma rehabilitation protocols, supporting both the physical and psychosocial dimensions of recovery in hospitalized trauma patients\n\nAdditional cohort of the study (pediatric trauma) population has been added.",[19,20,21,22,23,24,25],"Anxiety","Trauma","Hospitalized Adult Patients","Rehabilitation","Physical Mobility Impairment","Therapy Dog","Pediatric Patient (1m-21y)",[27,24,28,29,30,31,32],"Animal-Assisted Therapy","Trauma Patients","Early Mobilization","Anxiety Reduction","Pain Reduction","Human-Animal Interaction","INTERVENTIONAL","TREATMENT",[36],"NA",{"count":38,"type":39},128,"ESTIMATED",[41,45],{"type":14,"name":24,"description":42,"armGroupLabels":43},"Patients assigned to AAI in the morning received standard mobilization in the afternoon, and vice versa. In the AAI intervention, patients interacted with the therapy dog and handler",[44],"Animal-assisted intervention",{"type":14,"name":46,"description":47,"armGroupLabels":48},"Standard mobilization","Patients assigned to AAI in the morning received standard mobilization in the afternoon, and vice versa. Standard mobilization no therapy dog is present",[44],[50,54,58,61,65,68,71],{"measure":51,"description":52,"timeFrame":53},"Change in Defense & Veterans Pain Rating Scale","Before and after each intervention, patients completed surveys assessing pain using the (Defense and Veterans Pain Rating Scale, DVPRS). Scores on the scale ranged from 0: no pain to 10: worst pain of patient's life.","baseline and post intervention (1 day)",{"measure":55,"description":56,"timeFrame":57},"Change in General Anxiety Disorder-7 (GAD-7) Scale","Before and after each intervention, patients completed surveys assessing anxiety using modified General Anxiety Disorder-7 (GAD-7). Scaled from not at all to a lot, resulting in a total score that can range from not at all, a litte, some, a lot, with higher values reflecting more severe anxiety symptoms.","Baseline and post intervention (1 day)",{"measure":59,"description":60,"timeFrame":53},"General status","Before and after each intervention, patients completed surveys assessing general status. Used likert scale ranging from very poor to excellent.",{"measure":62,"description":63,"timeFrame":64},"Willingness to mobilize","Before and after each intervention, patients completed surveys assessing willingness to mobilize. Used likert scale ranging from no motivation at all to very much.","baseline and post intervention (1day)",{"measure":66,"description":67,"timeFrame":57},"Mobilization difficulty","Before and after each intervention, patients completed surveys assessing mobilization difficulty. Used likert scale ranging from very easy to very hard.",{"measure":69,"description":70,"timeFrame":57},"Overall mobility satisfaction","Before and after each intervention, patients completed surveys assessing overall mobility satisfaction. Used likert scale ranging from not satisfied to very satisfied.",{"measure":72,"description":73,"timeFrame":74},"Change in Wong-Baker Faces Scale","Before and after each intervention, pediatric patients will use Wong-Baker FACES Pain Rating Scale to assess pain. Scores on the scale ranged from 0: \"no hurt\" to 10: \"hurts worst.\" Participants ages 4-7 will use a modified FACES and 8-17 will use a regular FACES.","Baseline and post intervention (1day)",[],"ALL","4 Years","99 Years",{"inclusion":80,"exclusion":85,"raw_text":93},[81,82,83,84],"Adults (18 years of age and older)","trauma patients","emergency general surgery patients","pediatric patients (4 - 17 years old)",[86,87,88,89,90,91,92],"weight bearing limitation","spine instability","oxygen requirement \\>2LPM, GCS \\\u003C15,","high fall risk (as evidenced by door label)","fear of dogs","allergies to dogs","prisoners","Inclusion Criteria:\n\n* Adults (18 years of age and older)\n* trauma patients\n* emergency general surgery patients\n* pediatric patients (4 - 17 years old)\n\nExclusion Criteria:\n\n* weight bearing limitation\n* spine instability\n* oxygen requirement \\>2LPM, GCS \\\u003C15,\n* high fall risk (as evidenced by door label)\n* fear of dogs\n* allergies to dogs\n* prisoners",[95,96,97],"CHILD","ADULT","OLDER_ADULT",[99],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":114},"University of Kentucky Albert B. Chandler Hospital","Lexington","Kentucky","40515-9578","United States",[106,111],{"name":107,"role":108,"phone":109,"email":110},"Jessica C Borzansky","CONTACT","8593586642","jcbo251@uky.edu",{"name":112,"role":108,"email":113},"Andrew C Bernard, MD","andrew.bernard@uky.edu",{"lat":115,"lon":116},37.98869,-84.47772,[118],{"name":119,"role":108,"phone":120,"email":113},"Andrew Bernard, MD","8593236346",[122],{"name":119,"affiliation":123,"role":124},"University of Kentucky","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":128,"biomarkers":131},[129,130],"Emergency General Surgery","Injury",[],{"nct_id":4,"found":133,"summary":134,"prompt_version":144},true,{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is an interventional study with an estimated 128 participants. It uses a randomized crossover design, meaning you will experience both interventions (with and without a therapy dog) in a random order.","completed","Animal-Assisted Therapy for Hospitalized Trauma Patients","This study is exploring whether walking with a therapy dog, called Animal Assisted Therapy (AAI), can help adult and pediatric trauma patients move more during their hospital stay. Early movement after an injury or surgery is important for recovery, but pain and anxiety can make it difficult. You would participate in two walking sessions: one with a certified therapy dog and handler, and one without a dog (standard mobilization). The order of these sessions is random. Before and after each walk, you'll complete short surveys about your pain, anxiety, and general status. Researchers will also measure how far and long you walk. This study is for trauma patients aged 4 to 99 years old, but excludes those with weight-bearing limitations, spine instability, high oxygen needs, low GCS scores, high fall risk, fear of dogs, dog allergies, or who are prisoners. The study aims to see if AAI helps reduce pain and anxiety and improves your ability to move.","Your pain, anxiety, and general status are measured at baseline and post-intervention (1 day).",158,"You would participate in two walking sessions during your hospital stay. Before and after each session, you will complete short surveys.","Not stated in the trial record.",[24,46],"v2"]