[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05501834":3,"trial-entities:NCT05501834":91,"trial-summary:NCT05501834":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":53,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":14,"eligibility_criteria":63,"std_ages":73,"locations":75,"central_contacts":84,"overall_officials":85,"references":89,"see_also_links":90},"NCT05501834","IRB-P00039559","Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial","ENROLLING_BY_INVITATION","2028-10-01","2026-06","2026-06-30","2024-04-01","Boston Children's Hospital","OTHER",false,"This study aims to determine if removing supracondylar pins immediately following cast removal and prior to X-ray and\u002For using a VR headset during pin removal decreases patient and parent\u002Fguardian anxiety compared to pin removal following cast removal and X-ray and\u002For without the use of a VR headset. The research team hypothesizes that patient anxiety response will be lower when pins are removed immediately following cast removal and will be lower when patient uses a VR headset compared to our current standard of care. Secondarily, this study will determine if there is an association between patient anxiety response and their parent's\u002Fguardian's anxiety.","Supracondylar humerus (SCH) fractures are one of the most common pediatric injuries.1-5 These fractures are reported as the second most common pediatric fracture, constituting about 18% of all pediatric fractures and approximately 60% of all elbow fractures.1,3,5 The median age of injury is between 3 and 8 years old, peaking at 5 to 6 years old.1,3 The gold standard for treating displaced SCH fractures is closed reduction and percutaneous pinning (CRPP);4,6-10 pins are almost always removed three to four weeks post-surgery in outpatient clinics, without anesthesia.11\n\nMany would assume that patients experience anxiety during pin removal, but no studies to our knowledge quantified a patient's physiological and behavioral response during this procedure. However, there have been many in-depth investigations of these responses during cast removal procedures, where heart rate (HR) is used as a psychological indicator of anxiety.12-14 Additionally, Merkel et al. developed the Face, Legs, Activity, Cry and Consolability (FLACC) Scale which is a valid and reliable tool to quantify pain behaviors in children.15 Further research showed that the FLACC Scale was also sensitive to painless procedures (i.e. intravenous insertion), and therefore, it can be considered a composite of pain and distress (anxiety).16\n\nAnxiety in the medical setting has been linked to future adverse effects for children.17-19 Previous publications have shown that patients with anxiety in the perioperative setting have increased postoperative pain, maladaptive behavior, and long-term anxiety with future medical visits.17,18 Preoperative anxiety in children also has been reported to have similar negative effects on behavior.20,21 It is plausible that an anxiety-provoking procedure, such as pin removal, would have similar effects.\n\nThe primary purpose of the first phase of this study (IRB-P00028933), which took place from 2018 to 2020, was to quantify the anxiety experienced by patients undergoing pin removal in clinic following closed reduction and percutaneous pinning (CRPP) for SCH fractures. Now that the first phase is complete, the research team is interested in taking this research another step forward to see how healthcare providers can reduce patient and parent anxiety in clinical settings. Before the first phase of this study, there were no known studies that quantified a patient's physiological and behavioral response during a postoperative pin removal procedure, as CRPP is the gold standard treatment for displaced supracondylar humerus (SCH) fractures. The findings of the primary purpose of the first phase ultimately demonstrated that all patients undergoing pin removal experience an anxiety response, therefore highlighting an area of clinical practice in need of a targeted to help decrease patient anxiety and improve patient experience.\n\nPatients currently proceed with the following clinical flow on the day of their pin removal: (1) patients first present to the cast room for cast removal, (2) radiographs are obtained to confirm alignment and fracture stability, and (3) patients are seen by their provider in an orthopaedic clinic room for pin removal. While this process is streamlined in a busy orthopaedic clinic, it could still take up to an hour of time. After cast removal may also be the first time a patient sees the pins and this added time before pin removal could escalate anxiety. It is evident in the literature that an X-ray prior to pin removal is unnecessary, as it does not change clinical management.6,22,23 Anxiety in the medical setting has been linked to future adverse effects for children, such as increased postoperative pain, maladaptive behavior, and long-term anxiety with future medical visits.17-19 It is plausible that an anxiety-provoking procedure, such as pin removal, could have similar effects. Ultimately, the findings of the first phase of our study provide the groundwork for future research efforts in techniques to minimize anxiety for the pediatric patient having to undergo pin removal. Something as simple as changing the clinic flow of our current pin removal process, such as removing pins immediately following cast removal and prior to X-ray, may decrease the overall time waiting for pin removal and decrease patient anxiety.\n\nThe use of virtual reality is currently being studied at several institutions as a form of distraction to reduce pain and anxiety in children during anxiety-inducing procedures, such as blood draws. It is evident from these recent studies that virtual reality successfully decreases the pain and anxiety in children when used in needle-related procedures.24-26 Procedure-related pain and anxiety were quantified using various pain scales and shown to be reduced in the VR groups, as compared with the controls.24-26 The pin removal procedure is known to produce elevated anxiety in patients, therefore we believe it is appropriate to apply this literature to our own research and determine anxiety levels after using VR during this procedure.\n\nTherefore, the primary aim of this study is to determine if removing supracondylar pins immediately following cast removal and prior to X-ray decreases patient and parent\u002Fguardian anxiety compared to pin removal following cast removal and X-ray. It is hypothesized that patient anxiety response will be lower when pins are removed immediately following cast removal compared to our current standard of care. Secondarily, this study will aim to determine if there is an association between patient anxiety response and their parent's\u002Fguardian's anxiety. Thirdly, this study will aim to determine if the use of virtual reality (VR) has an influence on the patient anxiety response during the pin removal procedure.",[18,19],"Supracondylar Humerus Fracture","Anxiety",[21,18,19],"Closed reduction percutaneous pinning","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},140,"ESTIMATED",[30,35,40],{"type":13,"name":31,"description":32,"armGroupLabels":33},"Supracondylar Pin Removal After Imaging With VR","Patients in the treatment group will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. Wear the VR headset, 4. Have pins pulled in clinic room by provider.",[34],"Intervention Group 1",{"type":13,"name":36,"description":37,"armGroupLabels":38},"Supracondylar Pin Removal Before Imaging","Patients in the intervention 1 group will: 1. Go to cast room for cast removal, 2. Have pins pulled in cast room by provider, 3. Go to radiology for X-ray, 4. Have clinic visit with provider",[39],"Intervention Group 2",{"type":13,"name":41,"description":42,"armGroupLabels":43},"Supracondylar Pin Removal Before Imaging With VR","Patients in the intervention group 2 will: 1. Go to cast room for cast removal, 2. Wear the VR headset, 3. Have pins pulled in cast room by provider, 4. Go to radiology for X-ray",[44],"Intervention Group 3",[46,50],{"measure":47,"description":48,"timeFrame":49},"Face, Legs, Activity, Cry and Consolability (FLACC) scale","The Face, Legs, Activity, Cry and Consolability scale is validated in both young, non-verbal children and older, verbal children. The FLACC scale measures a patient's response to pain or distress using assessments of (1) facial expression, (2) leg movement, (3) activity, (4) extent to which they cried, and (5) extent to which they are consoled on a scale from 0 to 2 to generate a total score ranging from 0 (no pain\u002Fdistress) to 10 (maximum pain\u002Fdistress), with a higher score representing higher rates of anxiety and stress.","During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)",{"measure":51,"description":52,"timeFrame":49},"Heart rate","Heart rate will be measured using a pulse oximetry heart rate monitor. We plan to use heart rate as a physiological correlate to the FLACC scale. For the purposes of this study, we will define an anxiety response as any patient who scores greater than 0 on the FLACC or achieves a HR in excess of the upper 95% normative limits for their age, sex and race (where applicable).",[54,57],{"measure":55,"description":56,"timeFrame":49},"Spielberger State-Trait Anxiety Inventory (STAI-5)","The Spielberger State-Trait Anxiety Inventory (STAI-5) has been widely used to measure the state and trait components of anxiety. The STAI has been shown to have excellent psychometric properties with good reliability and validity. The questionnaire can measure anxiety both in healthy and in clinical populations, with those scoring higher on STAI scales indicating to be more prone to experience anxiety. We plan to use this to measure the parent\u002Fguardian anxiety response to patient pin removal.",{"measure":58,"description":59,"timeFrame":49},"Timing","The average length of time pin removal takes within each arm of the sturdy.","ALL","3 Years","10 Years",{"inclusion":64,"exclusion":69,"raw_text":72},[65,66,67,68],"Aged 3 to ≤10 years at time of surgery","Supracondylar humerus fractures that are laterally pinned at Boston Children's Hospital","Scheduled visit for pin removal at either Boston or Waltham orthopedic clinic by a study-participating physician","English speaking",[70,71],"Documented history of seizure disorders or other neurological disorders.","Patients unwilling to follow up in Boston or Waltham BCH clinic locations","Inclusion Criteria:\n\n* Aged 3 to ≤10 years at time of surgery\n* Supracondylar humerus fractures that are laterally pinned at Boston Children's Hospital\n* Scheduled visit for pin removal at either Boston or Waltham orthopedic clinic by a study-participating physician\n* English speaking\n\nExclusion Criteria:\n\n* Documented history of seizure disorders or other neurological disorders.\n* Patients unwilling to follow up in Boston or Waltham BCH clinic locations",[74],"CHILD",[76],{"facility":12,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"Boston","Massachusetts","02215","United States",{"lat":82,"lon":83},42.35843,-71.05977,[],[86],{"name":87,"affiliation":12,"role":88},"Yi-Meng Yen, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[19,93],"Supracondylar fracture of humerus",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":107},true,{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an interventional study that plans to enroll 140 participants. It compares different approaches to pin removal, including the use of a VR headset.","completed","Anxiety Surrounding Supracondylar Pin Removal in Children","This study is looking at ways to reduce anxiety in children aged 3 to 10 years old when they have pins removed after a supracondylar humerus fracture (a common elbow break). Researchers want to see if removing the pins right after the cast comes off, before an X-ray, or using a virtual reality (VR) headset during the pin removal, helps lower anxiety for both the child and their parent. They will measure anxiety using a scale called FLACC (Face, Legs, Activity, Cry and Consolability) and by checking heart rate. The study is currently unclear on its recruitment status and aims to enroll 140 participants.","Anxiety and heart rate will be measured during the pin removal visit.",104,"Participants will have their cast removed, pins pulled, and an X-ray. Some groups will use a VR headset during pin removal.","Not stated in the trial record.",[],"v2"]