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.
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.
Brief Title
Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room
Categories
Completion Date
Completion Date Type
Actual
Conditions
Procedural Anxiety
Laceration of Skin
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)
* 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)
Inclusion 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
* children 5-13 years of age
* present to ED during the study period with non-facial lacerations
* patient to undergo wound closure with sutures
Gender
All
Gender Based
false
Keywords
procedural anxiety
virtual reality
anxiolysis
laceration repair
pediatric
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
13 Years
Minimum Age
5 Years
NCT Id
NCT03475901
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-8466
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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).
Outcome Measure
The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
Outcome Time Frame
from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
Outcome Measure
Change in anxiety score
Outcome Description
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).
Outcome Time Frame
from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
Outcome Measure
Change in anxiety score
Outcome Description
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).
Outcome Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Outcome Measure
Change in anxiety score
Outcome Description
To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, participants will be asked to complete a brief questionnaire at the end of the procedure assessing their experience while using VR during the laceration repair.
These surveys address the patient's comfort and satisfaction with the technology. We have created separate patient surveys for children ages 5-7 and children ages 8-13 - these surveys have the same questions, but the answer choices are simplified from Likert Rating Scales (scale of 1 - 5) for the older children to a simple "Yes, No, I don't know" choice for the younger children. There is also a free text response question for which patients can provide additional comments or suggestions regarding their use of VR during laceration repair.
These surveys address the patient's comfort and satisfaction with the technology. We have created separate patient surveys for children ages 5-7 and children ages 8-13 - these surveys have the same questions, but the answer choices are simplified from Likert Rating Scales (scale of 1 - 5) for the older children to a simple "Yes, No, I don't know" choice for the younger children. There is also a free text response question for which patients can provide additional comments or suggestions regarding their use of VR during laceration repair.
Outcome Time Frame
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
Outcome Measure
Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
Outcome Description
To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, parents/guardians will be asked to complete a brief survey at the end of the procedure assessing their comfort and satisfaction with their child's use of VR during the laceration repair. The survey contains both rating questions with Likert Rating Scales (scale of 1 - 5), yes/no questions, and questions with free text responses.
Outcome Time Frame
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
Outcome Measure
Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
Outcome Description
The ED provider who performed the laceration repair will complete a survey at the end of the procedure assessing their satisfaction with using VR during laceration repair. The survey contains yes/no questions, multiple choice questions, and questions with free text responses.
Outcome Time Frame
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
Outcome Measure
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
Outcome Description
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, adjunctive measures were needed during the procedure.
Outcome Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Outcome Measure
Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
Outcome Description
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
Outcome Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Outcome Measure
Headache due to VR use as reported on a qualitative simulator sickness questionnaire
Outcome Description
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
Outcome Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Outcome Measure
Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
Outcome Description
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
Outcome Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Outcome Measure
Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
Outcome Description
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
Outcome Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Outcome Measure
Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
Outcome Description
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, barriers to the use of VR that they encountered during the procedure
Outcome Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Outcome Measure
Barriers to the use of VR identified during this study as reported on a provider questionnaire
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
13
Minimum Age Number (converted to Years and rounded down)
5
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Fein
Investigator Email
dfein@montefiore.org
Investigator Phone
718-320-5312