【ChiCTR2000030547】Effects of virtual reality intervention on pain and anxiety among paediatric patients undergoing nasopharyngeal swab in emergency department: A randomized controlled trial

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基本信息

登记号

ChiCTR2000030547

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2020-03-07

临床申请受理号

靶点

适应症

呼吸道疾病

试验通俗题目

Effects of virtual reality intervention on pain and anxiety among paediatric patients undergoing nasopharyngeal swab in emergency department: A randomized controlled trial

试验专业题目

Effects of virtual reality intervention on pain and anxiety among paediatric patients undergoing nasopharyngeal swab in emergency department: A randomized controlled trial

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临床试验信息

试验目的

(1) Compare the effects of VR intervention in paediatric patients undergoing NPS on pain, anxiety, stress, heart rate, and emotional manifestations with those of standard care. (2) Compare the effects of VR intervention in paediatric patients’ pain and anxiety levels as rated by parents/ legal guardians with those of standard care. (3) Compare the effects of VR intervention on improving satisfaction of parents/ legal guardians with regard to NPS procedures with those of standard care.

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Eligible participants will be randomly assigned in a 1:1: ratio to the control group who will receive standard care and the intervention group who will receive VR intervention and standard care using stratified permuted block randomization with a block size of 6 to maintain a good balance of participants

盲法

Group allocation will be concealed from the nurses, AED doctors, paediatric patients, and parents/ legal guardians until consent and baseline assessment data has been obtained.

试验项目经费来源

试验范围

目标入组人数

150

实际入组人数

第一例入组时间

2020-03-06

试验终止时间

2022-07-31

是否属于一致性

入选标准

Eligible pediatric patients: (1) aged between 3 and 14 years; (2) scheduled to undergo NPS; (3) able to communicate in Cantonese and follow instructions.；

排除标准

Potential participants will be excluded according to the followings: (1) enrolled in the proposed study previously; (2) triaged as category 1 (critically) and 2 (emergency) as these patients are critically ill; (3) identified cognitive and learning problems in their medical record and (4) previous history of seizures. Accompany parents/ legal guardians who are not able to read and write Chinese will also be excluded.；

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