Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial (NCT05501834) | Clinical Trial Compass
By InvitationNot Applicable
Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial
United States140 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range
3 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 3 to ≤10 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:
* Documented history of seizure disorders or other neurological disorders.
* Patients unwilling to follow up in Boston or Waltham BCH clinic locations
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Face, Legs, Activity, Cry and Consolability (FLACC) scale
Timeframe: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)
2
Heart rate
Timeframe: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning)