VR for Anxiety During Pin Removal

SM
RS
BP
Overseen ByBecky Parmeter, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

YY

Yi-Meng Yen, MD, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 3 to 8 who had a specific type of elbow fracture (supracondylar humerus) treated with pins at Boston Children's Hospital. They must be scheduled for pin removal by a participating doctor and speak English.

Inclusion Criteria

English speaking
I am between 3 and 10 years old.
I had a supracondylar humerus fracture fixed with lateral pins at Boston Children's Hospital.
See 1 more

Exclusion Criteria

I am not willing to attend follow-up visits at Boston or Waltham BCH clinics.
I have a history of seizures or neurological disorders.

What Are the Treatments Tested in This Trial?

Interventions

  • Supracondylar Pin Removal

Trial Overview

The study compares anxiety levels in kids during pin removal using different methods: removing pins before or after an X-ray, and whether or not the child uses a VR headset during the procedure. Participants are randomly assigned to these groups.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Group 3Experimental Treatment1 Intervention
Group II: Intervention Group 2Experimental Treatment1 Intervention
Group III: Intervention Group 1Experimental Treatment1 Intervention
Group IV: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+