Clinical trial NCT03475901: Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room
Official title: A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Anxiety
Laceration of Skin
Keywords: procedural anxiety
virtual reality
anxiolysis
laceration repair
pediatric
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: KindVR
First posted: 2018-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
timeFrame: from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
Secondary outcomes:
measure: Change in anxiety score
timeFrame: from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
measure: Change in anxiety score
timeFrame: from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
measure: Change in anxiety score
timeFrame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
measure: Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
timeFrame: 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
measure: Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
timeFrame: 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
measure: Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
timeFrame: 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
measure: Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
timeFrame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
measure: Headache due to VR use as reported on a qualitative simulator sickness questionnaire
timeFrame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
measure: Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
timeFrame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
measure: Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
timeFrame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
measure: Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
timeFrame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
measure: Barriers to the use of VR identified during this study as reported on a provider questionnaire
timeFrame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Daniel M Fein, MD
role: PRINCIPAL_INVESTIGATOR
References: