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

This study aims to determine if removing supracondylar pins immediately following cast removal and prior to X-ray and/or using a VR headset during pin removal decreases patient and parent/guardian anxiety compared to pin removal following cast removal and X-ray and/or 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/guardian's anxiety.

Study Overview

• Status: Enrolling by invitation
• Conditions: Anxiety; Supracondylar Humerus Fracture
• Intervention / Treatment: Other: Supracondylar Pin Removal After Imaging With VR; Other: Supracondylar Pin Removal Before Imaging; Other: Supracondylar Pin Removal Before Imaging With VR

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Documented history of seizure disorders or other neurological disorders.
• Patients unwilling to follow up in Boston or Waltham BCH clinic locations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Arm 1: Control Group Patients in the control group will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. Be seen in clinic room for pin removal. These steps are our current standard of care. An orthopedic cast room technician bivalves and removes the top half of the patient's cast. In radiology, anteroposterior (AP) and lateral X-ray views are obtained to confirm radiographic healing. In the clinic room, a surgeon or nurse removes the pins using pin removal pliers
Experimental: Intervention Group 1; Arm 2: No change in clinic order, VR headset intervention Patients in arm two will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. Receive a VR headset to wear while in clinic room, 4. Be seen in clinic room for pin removal	Other: 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.
Experimental: Intervention Group 2; Arm 3: Change in clinic order, no VR headset intervention Patients in arm three will: 1. Go to cast room for cast removal, 2. Have pins immediately pulled after cast removal, 3. Go to radiology for X-ray, 4. Be seen in clinic room by provider	Other: 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
Experimental: Intervention Group 3; Arm 4: Change in clinic order and VR headset intervention Patients in arm four will: 1. Receive a VR headset to wear while in cast room, 2. Go to cast room for cast removal, 3. Have pins immediately pulled after cast removal, 4. Go to radiology for X-ray, 5. Be seen in clinic room by provider	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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/distress) to 10 (maximum pain/distress), with a higher score representing higher rates of anxiety and stress.	During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)
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).	During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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/guardian anxiety response to patient pin removal.	During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)
Timing	The average length of time pin removal takes within each arm of the sturdy.	During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Yi-Meng Yen, MD, PhD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Closed reduction percutaneous pinning; Supracondylar Humerus Fracture
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IRB-P00039559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No