Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial

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

Many 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

Anxiety 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.

The 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.

Patients 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.

The 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.

Therefore, 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/guardian 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/guardian'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.

• Spielberger State-Trait Anxiety Inventory (STAI-5) [Time frame: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)]
• Timing [Time frame: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)]