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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT05501834
Status
Enrolling By Invitation

Conditions

  • Anxiety
  • Supracondylar Humerus Fracture

Eligibility Criteria

Sex
ALL
Age
3 Years - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • Supracondylar Pin Removal After Imaging With VR — OTHER
    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.
  • Supracondylar Pin Removal Before Imaging — OTHER
    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
  • Supracondylar Pin Removal Before Imaging With VR — OTHER
    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

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Jun 2026
Primary completion
Jul 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    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
  • Experimental: Intervention Group 1
    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
  • Experimental: Intervention Group 2
    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
  • Experimental: Intervention Group 3
    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

Primary Outcome Measure

Face, Legs, Activity, Cry and Consolability (FLACC) scale [ Time Frame: During Treatment (Pin Removal Visit post closed reduction and percutaneous pinning) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02215-

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By research site
Boston Children's Hospital· Boston, MA

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