Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room
2019年12月1日 更新者：Daniel Marc Fein、Montefiore Medical Center
A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing 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.
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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New York
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Bronx、New York、美国、10467
- Children's Hospital at Montefiore
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
5年 至 13年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Virtualy 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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
大体时间：from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
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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).
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from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in anxiety score
大体时间：from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
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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).
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from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
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Change in anxiety score
大体时间：from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
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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).
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from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
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Change in anxiety score
大体时间：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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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).
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from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
大体时间：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
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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
|
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Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
大体时间：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.
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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
|
|
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
大体时间：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.
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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
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Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
大体时间：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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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.
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from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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Headache due to VR use as reported on a qualitative simulator sickness questionnaire
大体时间：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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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.
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from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
大体时间：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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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.
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from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
大体时间：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.
|
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
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Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
大体时间：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.
|
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
|
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Barriers to the use of VR identified during this study as reported on a provider questionnaire
大体时间：from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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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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from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年4月15日
初级完成 (实际的)
2019年11月22日
研究完成 (实际的)
2019年11月22日
研究注册日期
首次提交
2018年3月10日
首先提交符合 QC 标准的
2018年3月16日
首次发布 (实际的)
2018年3月23日
研究记录更新
最后更新发布 (实际的)
2019年12月3日
上次提交的符合 QC 标准的更新
2019年12月1日
最后验证
2019年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Virtual Reality App的临床试验
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Southern Methodist UniversityKing's College London完全的
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IRCCS Eugenio Medea招聘中
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Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de Barcelona招聘中
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Hospital Universitari Vall d'Hebron Research Institute主动，不招人
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University of WashingtonNational Institute of Dental and Craniofacial Research (NIDCR)邀请报名