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

NCT05501834 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-06-30

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 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.

Conditions

  • Supracondylar Humerus Fracture
  • Anxiety

Interventions

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.

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

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

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
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2028-07-01
Completion
2028-10-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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