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临床试验/NCT05708586
NCT05708586终止不适用

Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures

University of Michigan2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
66
试验地点
2
主要终点
Child Anxiety (7 Years Old and Older)

研究概览

简要总结

The purpose of this study is to demonstrate that the use of a virtual reality experience can decrease child and caregiver anxiety and pain for simple orthopaedic office procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Child Anxiety (7 Years Old and Older)

时间窗: Up to 24 hours following procedure

Assessed by State-Trait Anxiety Inventory for Children (STAIC): 20 questions with 3 answer options for each question. Scores range from 20 to 60 with 60 being the higher (more or worse) anxiety on self-assessment.

Child Pain Score

时间窗: Up to 24 hours following procedure

Assessed by Wong-Baker Children's Faces Pain Scale: The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain.

Child Anxiety (Younger Than 7 Years Old)

时间窗: Up to 24 hours following procedure

Assessed by Children's Fear Scale: The Children's Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. Thus, the scale is 1-5 with 1 being least fear and 5 being greatest fear and anxiety.

次要结局

  • Parental Anxiety(Up to 24 hours following procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noelle Whyte

Clinical Assistant Professor

University of Michigan

研究点 (2)

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