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

NCT05501834 | Unknown

• 1 other identifier: IRB-P00039559
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims 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. The research team hypothesizes 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 determine if there is an association between patient anxiety response and their parent's/guardian's anxiety.

Conditions

Supracondylar Humerus Fracture; Anxiety

Keywords

Closed reduction percutaneous pinning; Supracondylar Humerus Fracture; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Face, Legs, Activity, Cry and Consolability (FLACC) scale

  During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

• Heart rate

  During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

• Spielberger State-Trait Anxiety Inventory (STAI-5)

  During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)

Study Arms (2)

Control Group

NO INTERVENTION

Both arms will receive the same Standard of Care procedures but will receive them in a different order. Patients in the control group will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. Will 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. The order of these procedures is the current Standard of Care.

Intervention Group

EXPERIMENTAL

Both arms will receive the same Standard of Care procedures but will receive them in a different order. Patients in the treatment group 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. Will be seen in clinic room by provider.

Other: Supracondylar Pin Removal Before Imaging

Interventions

Supracondylar Pin Removal Before Imaging OTHER

Patients in the treatment group 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. Will be seen in clinic room by provider. The order of these steps differs from our current standard of care, during which patients' pins are removed following cast removal and x-ray imaging.

Intervention Group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 3 to ≤8 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

You may not qualify if:

• Patient diagnosed with autism

Sponsors & Collaborators

• Boston Children's Hospital: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Yi-Meng Yen, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon McGurty, BS

CONTACT

617-919-4209; shannon.mcgurty@childrens.harvard.edu

Becky Parmeter, MPH

CONTACT

781-216-3080; Becky.Parmeter@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery, Harvard Medical School

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 15, 2022
• Study Start: October 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share