VR for Anxiety During Pin Removal
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?
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
Exclusion Criteria
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
Arm 4: Change in clinic order and VR headset intervention Patients in arm four will: 1. Receive a VR headset to wear while in cast room, 2. Go to cast room for cast removal, 3. Have pins immediately pulled after cast removal, 4. Go to radiology for X-ray, 5. Be seen in clinic room by provider
Arm 3: Change in clinic order, no VR headset intervention Patients in arm three 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. Be seen in clinic room by provider
Arm 2: No change in clinic order, VR headset intervention Patients in arm two will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. Receive a VR headset to wear while in clinic room, 4. Be seen in clinic room for pin removal
Arm 1: Control Group Patients in the control group will: 1. Go to cast room for cast removal, 2. Go to radiology for X-ray, 3. Be seen in clinic room for pin removal. These steps are our current standard of care. An orthopedic cast room technician bivalves and removes the top half of the patient's cast. In radiology, anteroposterior (AP) and lateral X-ray views are obtained to confirm radiographic healing. In the clinic room, a surgeon or nurse removes the pins using pin removal pliers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
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