Purpose

The investigators propose a pilot study to examine the feasibility of utilizing immersive virtual reality to reduce procedural anxiety in children undergoing non-facial laceration repair in the Pediatric Emergency Department. The investigators hypothesize that virtual reality will be well-received by patients and their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the immersive virtual reality experience.

Conditions

Eligibility

Eligible Ages
Between 5 Years and 13 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • children 5-13 years of age
  • present to ED during the study period with non-facial lacerations
  • patient to undergo wound closure with sutures

Exclusion Criteria

  • Patients with lacerations on the head/face
  • Patients with lacerations sustained in conjunction with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
  • Patients who sustained a laceration in conjunction with an open fracture
  • Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
  • Patients with a history of or current symptoms of vertigo
  • Patients who are blind
  • Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
  • Patients on whom the VR headset does not fit appropriately
  • Non-English speaking patients will be excluded from this study (we do not have funds available to translate the study documents into other languages)

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Virtualy Reality App
Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
  • Other: Virtual Reality App
    Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.

Recruiting Locations

Children's Hospital at Montefiore
Bronx, New York 10467
Contact:
Daniel M Fein, MD
718-920-5312
dfein@montefiore.org

More Details

NCT ID
NCT03475901
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Sondra M Nemetski, MD, PhD
646-283-3476
snemetsk@montefiore.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.