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临床试验/CTRI/2019/10/021588
CTRI/2019/10/021588尚未招募2 期

Effect of videodistraction on preoperative anxiety scores in paediatric patients undergoing general anaesthesia in ophthalmic day care procedures: A randomized controlled trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2020年12月3日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
138
试验地点
1
主要终点
To compare preoperative anxiety using mYPASS score in paediatric patients undergoing ophthalmic procedures under general anaesthesia using video distraction and parental presence with parental presence alone.

研究概览

简要总结

This is a randomized controlled double blinded trial to study the effect of video distraction on pre-operative anxiety scores(Modified Yale Preoperative anxiety scale) in paediatric patients undergoing general anaesthesia in ophthalmic daycare procedures.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children aged 2-8 years 2)ASA physical status 1 or 2 3)Undergoing elective ophthalmic outpatient surgery 4)Atleast one functional eye.

排除标准

  • ASA 3 or 4 2)Syndromic children 3)General exposures>3 4)Children who received preoperative anxiolytic medication like midazolam etc 5)Significant cognitive impairment or developmental delays impairing language or vision 6)Children on psychotropic medications.

结局指标

主要结局

To compare preoperative anxiety using mYPASS score in paediatric patients undergoing ophthalmic procedures under general anaesthesia using video distraction and parental presence with parental presence alone.

时间窗: Three timepoint: | 1)pre anaesthetic room | 2)During transport to operating room | 3)After introduction of anaesthetic mask

次要结局

  • To compare in the two groups:(1)Child fear)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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