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临床试验/ChiCTR2000030547
ChiCTR2000030547尚未招募Unknown

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

未提供0 个研究点目标入组 300 人开始时间: 2020年3月6日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
300
主要终点
Pain

研究概览

简要总结

(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.

研究设计

研究类型
Interventional
主要目的
随机平行对照
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.

入排标准

年龄范围
3 至 14(—)
性别
All

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.

研究组 & 干预措施

Intervention group

virtual reality intervention

Control group

standard care

结局指标

主要结局

Pain

时间窗: 5 minutes prior to the procedure (T0), immediately after the procedure (T2), and 5 minutes after the procedure (T3)

Anxiety

时间窗: 5 minutes prior to the procedure (T0), immediately after the procedure (T2), and 5 minutes after the procedure (T3)

Emotional manifestation

时间窗: During the procedure

次要结局

  • Stress(5 minutes prior to the procedure (T0), immediately after the procedure (T2), and 5 minutes after the procedure (T3))
  • Heart rate(5 minutes prior to the procedure (T0), immediately after the procedure (T2), and 5 minutes after the procedure (T3))
  • Children's pain rated by parents(Immediate after the procedure)
  • Children's anxiety rated by parents(Immediate after the procedure)
  • Parent's satisfaction(Immediate after the procedure)

研究者

发起方
未提供

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