Anxiety Surrounding Supracondylar Pin Removal in Children
This study is looking at ways to reduce anxiety in children aged 3 to 10 years old when they have pins removed after a supracondylar humerus fracture (a common elbow break). Researchers want to see if removing the pins right after the cast comes off, before an X-ray, or using a virtual reality (VR) headset during the pin removal, helps lower anxiety for both the child and their parent. They will measure anxiety using a scale called FLACC (Face, Legs, Activity, Cry and Consolability) and by checking heart rate. The study is currently unclear on its recruitment status and aims to enroll 140 participants.
- Study design
- This is an interventional study that plans to enroll 140 participants. It compares different approaches to pin removal, including the use of a VR headset.
- What's involved
- Participants will have their cast removed, pins pulled, and an X-ray. Some groups will use a VR headset during pin removal.
- Compensation
- Not stated in the trial record.
- Follow-up
- Anxiety and heart rate will be measured during the pin removal visit.
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Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Yi-Meng Yen, MD, PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Face, Legs, Activity, Cry and Consolability (FLACC) scaleDuring 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.
- Heart rateDuring 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).