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临床试验/NCT04472507
NCT04472507已完成不适用

Use of Virtual Reality (VR) in Pain and Anxiety Reduction in Inpatient Paediatric Venepuncture and Cannulation

Manchester University NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Perceived and reported pain/anxiety scores

研究概览

简要总结

Virtual Reality (VR) is technology that simulates an immersive 3 dimensional environment for the user and is often used for immersive gaming experiences. The investigators will use VR in children who undergo painful procedures such as blood sampling and cannulation to investigate if VR reduces pain. The study will be carried out in 32 children admitted to the Royal Manchester Children in the UK and will assess feasbility of use VR, child and parent reported pain and therefore generate pilot data. This data will be used to design larger randomised control studies.

详细描述

Objectives

  1. Conduct initial acceptability/feasibility testing of VRH use with children undergoing venepuncture or cannulation in an acute, often unplanned inpatient setting in a children's hospital.
  2. Assess level of child and parent reported pain during procedure as well as change in heart rate.
  3. Generate pilot data to design software and develop methods, outcome measures and patient/family engagement for a large randomised control trial (RCT) in the same setting to establish efficacy of VRH in reduction of perceived pain.

Outcome

  1. Perceived and reported pain/anxiety scores for children undergoing venepuncture or cannulation with VRH.
  2. Change in heart rate before, during and after painful procedure
  3. Clinicians' feedback on the use of VRH in inpatient painful procedures

STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS Practitioners will be encouraged to contact the research team each time they are to perform a procedure between 0830H and 1600H and, unless already with another child using VRH, the research team will come to speak to parents to consent to the study. If consent is obtained then the procedure will be performed using current standard care as well as use of a VRH. The Oculus Go is a cheap and quick to set up headset. Off the shelf software will be selected that will distract but not require the movement of both arms. Software such as The Blu, Ocean Rift and Pet lab will be selected, dependent upon the age of the patient.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients admitted as an inpatient in Royal Manchester Children's Hospital
  • Patient requiring venepuncture or intravenous cannulation
  • no specific medical diagnosis required for inclusion
  • Child age 5-12 years during the study period

排除标准

  • Child under the age of 5 years
  • Child over the age of 12 years
  • Child not requiring venepuncture or cannulation
  • Child with previous discomofort wearing VRH

结局指标

主要结局

Perceived and reported pain/anxiety scores

时间窗: immediately following procedure

Measures perceived and reported pain/anxiety scores for children undergoing venepuncture or cannulation with Virtual Reality Headsets. Wong Baker FACES Pain Rating Scale 0-10 will be used, with 0 representing "no hurt" and 10 "hurts worst".

次要结局

  • Child heart rate after procedure(immediately following procedure)
  • child heart rate before procedure(immediately prior to procedure)
  • Child heart rate during procedure(at any point during procedure)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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