NCT03475901已完成不适用
A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children 5-13 years of age
- •present to ED during the study period with non-facial lacerations
- •patient to undergo wound closure with sutures
排除标准
- •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)
结局指标
主要结局
The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
时间窗: 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).
次要结局
- Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire(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)
- Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
- Headache due to VR use as reported on a qualitative simulator sickness questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
- Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire(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(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)
- Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
- Change in anxiety score(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
- Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
- Barriers to the use of VR identified during this study as reported on a provider questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
- Nausea due to VR use as reported on a qualitative simulator sickness questionnaire(from enrollment to procedure completion, which typically ranges from 20 to 180 minutes)
研究者
Daniel Marc Fein
Assistant Professor of Pediatrics
Montefiore Medical Center
研究点 (2)
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