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临床试验/NCT05267704
NCT05267704已完成不适用

Evaluating the Feasibility of Virtual Reality for Procedural Sedation in Pediatric Renal Biopsy Patients

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures

研究概览

简要总结

The purpose of this study is to assess the use of virtual reality (VR) as an adjunct or alternative to pharmacologic sedation in pediatric patients undergoing renal biopsy.

详细描述

Children aged 5-17 scheduled for renal biopsy will be offered the option to use a virtual reality (VR) headset that displays an interactive game as part of their renal biopsy experience. The standard of care of sedation medications will still be available to patients who are unable to complete the procedure with only the VR headset without pharmacologic sedation. Pain and anxiety will be monitored continuously using validated scales by a pediatric hospitalist and sedation nurse. These providers, as well as patients and parents, may ask for additional medications for adequate analgesia and anxiolysis.

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 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • - Patients age 5-17 receiving a renal biopsy at the University of California, San Francisco (UCSF) Benioff Children's Hospital

排除标准

  • Patients who cannot lie supine for their renal biopsy will be excluded from the study
  • Patients with injuries to the head/face that would prohibit wearing a headset
  • Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
  • 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

研究组 & 干预措施

VR Arm

Experimental

Pediatric patients age 5-17 using the VR headset during renal biopsy.

干预措施: Oculus Go Virtual Reality Headset (Device)

结局指标

主要结局

Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures

时间窗: From arrival to procedural room to completion of procedure (~30 minutes)

Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome

Number of Parents Who "Agreed" or "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures

时间窗: From arrival to procedural room to completion of procedure (~30 minutes)

Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome

次要结局

  • Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter)(From arrival to procedural room to completion of procedure (~30 minutes))
  • Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale)(From arrival to procedural room to completion of procedure (~30 minutes))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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