Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room

NCT ID: NCT03475901

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2019-11-22

Brief Summary

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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.

Detailed Description

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Conditions

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Procedural Anxiety Laceration of Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual Reality App

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KindVR

UNKNOWN

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Daniel Marc Fein

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel M Fein, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Children's Hospital at Montefiore

The Bronx, New York, United States

Site Status

Countries

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United States

References

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Nemetski SM, Berman DI, Khine H, Fein DM. Virtual Reality as Anxiolysis During Laceration Repair in the Pediatric Emergency Department. J Emerg Med. 2022 Jul;63(1):72-82. doi: 10.1016/j.jemermed.2022.01.025. Epub 2022 Aug 5.

Reference Type DERIVED
PMID: 35934650 (View on PubMed)

Other Identifiers

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2017-8466

Identifier Type: -

Identifier Source: org_study_id

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