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Completed

NCT Number: NCT03475901

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

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.

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Key information

Conditions

Procedural Anxiety Laceration of Skin

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

virtual reality app

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • KindVR

Registry information

Official study title

A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2018
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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