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

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ClinicalTrials.gov Identifier: NCT03475901
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
KindVR
Information provided by (Responsible Party):
Daniel Marc Fein, Montefiore Medical Center

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.


Condition or disease Intervention/treatment Phase
Procedural Anxiety Laceration of Skin Device: KindVR Virtual Reality Platform Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Tears


Intervention Details:
  • Device: KindVR Virtual Reality Platform
    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 Measures :
  1. The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale [ Time Frame: from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes ]
    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 :
  1. Change in anxiety score [ Time Frame: from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes ]
    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).

  2. Change in anxiety score [ Time Frame: from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes ]
    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).

  3. Change in anxiety score [ Time Frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes ]
    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).

  4. Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire [ 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 ]

    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.


  5. Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire [ 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 ]
    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.

  6. Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire [ 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 ]
    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.

  7. Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire [ Time Frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes ]
    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.

  8. Headache due to VR use as reported on a qualitative simulator sickness questionnaire [ Time Frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes ]
    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.

  9. Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire [ Time Frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes ]
    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.

  10. Nausea due to VR use as reported on a qualitative simulator sickness questionnaire [ Time Frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes ]
    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.

  11. Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire [ Time Frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes ]
    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.

  12. Barriers to the use of VR identified during this study as reported on a provider questionnaire [ Time Frame: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes ]
    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



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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475901


Contacts
Contact: Sondra M Nemetski, MD, PhD 646-283-3476 snemetsk@montefiore.org
Contact: Daniel M Fein, MD 718-920-5312 dfein@montefiore.org

Locations
United States, New York
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Daniel M Fein, MD    718-920-5312    dfein@montefiore.org   
Sub-Investigator: Daniel M Fein, MD         
Sponsors and Collaborators
Montefiore Medical Center
KindVR
Investigators
Principal Investigator: Daniel M Fein, MD Montefiore Medical Center

Responsible Party: Daniel Marc Fein, Assistant Professor of Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03475901     History of Changes
Other Study ID Numbers: 2017-8466
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Marc Fein, Montefiore Medical Center:
procedural anxiety
virtual reality
anxiolysis
laceration repair
pediatric

Additional relevant MeSH terms:
Anxiety Disorders
Emergencies
Lacerations
Mental Disorders
Disease Attributes
Pathologic Processes
Wounds and Injuries