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

Procedural Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475901
• Other study ID #: 2017-8466
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: November 22, 2019

Study information

• Verified date: December 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Emergencies
• Laceration of Skin
• Lacerations
• Procedural Anxiety

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital at Montefiore	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	KindVR

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
Secondary	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).	from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
Secondary	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).	from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Secondary	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.	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
Secondary	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.	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
Secondary	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.	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
Secondary	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.	from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Secondary	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.	from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Secondary	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.	from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Secondary	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.	from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Secondary	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.	from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Secondary	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	from enrollment to procedure completion, which typically ranges from 20 to 180 minutes