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

NCT03475901 | Completed DMC

• 1 other identifier: 2017-8466
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Anxiety; Laceration of Skin

Keywords

procedural anxiety; virtual reality; anxiolysis; laceration repair; pediatric

Outcome Measures

Primary Outcomes (1)

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

  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).

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

Secondary Outcomes (12)

• Change in anxiety score

  from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes

• Change in anxiety score

  from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes

• Change in anxiety score

  from enrollment to procedure completion, which typically ranges from 20 to 180 minutes

• 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

• 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

Study Arms (1)

Virtualy Reality App

EXPERIMENTAL

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

Interventions

Virtual Reality App 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.

Virtualy Reality App

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead
• KindVR: collaborator

Study Sites (1)

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 35934650 DERIVED

Study Officials

• Daniel M Fein, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: March 23, 2018
• Study Start: April 15, 2018
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)