A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room

Montefiore Medical Center1 site in 1 country40 target enrollmentApril 15, 2018

ConditionsProcedural Anxiety Laceration of Skin

Overview

Phase: N/A
Intervention: Not specified
Conditions: Procedural Anxiety
Sponsor: Montefiore Medical Center
Enrollment: 40
Locations: 1
Primary Endpoint: The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 15, 2018

End Date

November 22, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Montefiore Medical Center

Responsible Party

Principal Investigator

Daniel Marc Fein

Assistant Professor of Pediatrics

Montefiore Medical Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale

Time Frame: from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes

Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).

Secondary Outcomes

Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire(Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment)
Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
Headache due to VR use as reported on a qualitative simulator sickness questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire(Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment)
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire(Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment)
Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
Change in anxiety score(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
Barriers to the use of VR identified during this study as reported on a provider questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
Nausea due to VR use as reported on a qualitative simulator sickness questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)