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

NCT05501834 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-10-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Yi-Meng Yen, MD, PhD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-09-01
Completion
2024-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05501834 on ClinicalTrials.gov