A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 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)
研究组 & 干预措施
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.
干预措施: Virtual Reality App (Other)
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
- 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)
- 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)
- Change in anxiety score(from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes)
- Change in anxiety score(from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes)
研究者
Daniel Marc Fein
Assistant Professor of Pediatrics
Montefiore Medical Center