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

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ClinicalTrials.gov Identifier: NCT05501834
Recruitment Status : Not yet recruiting
First Posted : August 15, 2022
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
Yi-Meng Yen, Boston Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Supracondylar Humerus Fracture Anxiety Other: Supracondylar Pin Removal Before Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Control Group
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.
Experimental: Intervention Group
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
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.




Primary Outcome Measures :
  1. Face, Legs, Activity, Cry and Consolability (FLACC) scale [ Time Frame: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning) ]
    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.

  2. Heart rate [ Time Frame: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning) ]
    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).


Secondary Outcome Measures :
  1. Face, Legs, Activity, Cry and Consolability (FLACC) scale [ Time Frame: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning) ]
    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.

  2. Heart rate [ Time Frame: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning) ]
    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).

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



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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient diagnosed with autism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05501834


Contacts
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Contact: Shannon McGurty, BS 6179194209 shannon.mcgurty@childrens.harvard.edu
Contact: Ryan Sanborn Ryan.Sanborn@childrens.harvard.edu

Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Yi-Meng Yen, MD, PhD Boston Children's Hospital
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Responsible Party: Yi-Meng Yen, Assistant Professor of Orthopedic Surgery, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT05501834    
Other Study ID Numbers: IRB-P00039559
First Posted: August 15, 2022    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yi-Meng Yen, Boston Children's Hospital:
Closed reduction percutaneous pinning
Supracondylar Humerus Fracture
Anxiety
Additional relevant MeSH terms:
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Humeral Fractures
Anxiety Disorders
Mental Disorders
Fractures, Bone
Wounds and Injuries
Arm Injuries