Back to resultsVirtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room
Primary Purpose
Procedural Anxiety, Laceration of Skin
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality App
Sponsored by
About this trial
This is an interventional treatment trial for Procedural Anxiety focused on measuring procedural anxiety, virtual reality, anxiolysis, laceration repair, pediatric
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)
Sites / Locations
- Children's Hospital at Montefiore
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtualy Reality App
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in anxiety score
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).
Change in anxiety score
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).
Change in anxiety score
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).
Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
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.
Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
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.
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
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.
Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
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.
Headache due to VR use as reported on a qualitative simulator sickness questionnaire
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.
Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
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.
Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
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.
Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
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.
Barriers to the use of VR identified during this study as reported on a provider questionnaire
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
Full Information
NCT ID
NCT03475901
First Posted
March 10, 2018
Last Updated
December 1, 2019
Sponsor
Montefiore Medical Center
Collaborators
KindVR
1. Study Identification
Unique Protocol Identification Number
NCT03475901
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
KindVR
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Anxiety, Laceration of Skin
Keywords
procedural anxiety, virtual reality, anxiolysis, laceration repair, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtualy Reality App
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Virtual Reality App
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
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).
Time Frame
from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
Secondary Outcome Measure Information:
Title
Change in anxiety score
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).
Time Frame
from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
Title
Change in anxiety score
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).
Time Frame
from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
Title
Change in anxiety score
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).
Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Title
Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
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.
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
Title
Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
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.
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
Title
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
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.
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
Title
Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
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.
Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Title
Headache due to VR use as reported on a qualitative simulator sickness questionnaire
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.
Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Title
Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
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.
Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Title
Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
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.
Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Title
Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
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.
Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Title
Barriers to the use of VR identified during this study as reported on a provider questionnaire
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
Time Frame
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Fein, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room
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