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临床试验/NCT01858142
NCT01858142已完成不适用

Preparing Parents to be Present for Their Child's Anesthesia Induction: A Randomized Control Effectiveness Trial

IWK Health Centre2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
Modified Yale Pre-Operative Anxiety Scale

研究概览

简要总结

Children are distressed at anesthesia induction and this distress can result in maladaptive recovery outcomes. Having parents be present at anesthesia induction (PPIA) has been suggested as a potential intervention to decrease children's distress, and this intervention is widely favored by parents. However, to date, PPIA has not been found to be effective in reducing children's anxiety. The lack of efficacy may be attributable to the fact that parents have generally not been prepared for PPIA. The one study that prepared parents (as part of a larger preoperative preparation program) found that PPIA with preparation was superior to PPIA as previously studied (without preparation). Unfortunately, this program is resource intensive and therefore is not clinically feasible. This study will compare PPIA with a clinically feasible preparation program to PPIA with standard care (minimal preparation). Should our intervention show evidence of efficacy, the investigators will have designed a program that is easily translatable to everyday clinical practice. This will, in turn, reduce children's anxiety, improve postoperative outcomes and increase parental satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 2 to 10
  • Scheduled for elective surgical procedure at IWK Health Centre
  • Mask induction
  • ASA classification I or II

排除标准

  • Intravenous induction
  • Diagnosed development delay
  • ASA classification III or higher
  • Pre-medication with benzodiazepine

结局指标

主要结局

Modified Yale Pre-Operative Anxiety Scale

时间窗: post-treatment (following intervention); average=15 minutes after treatment

Yale Preoperative Anxiety Scale (mYPAS; Kain et al., 1997). This researcher completed measure is made up of 5 categories (e.g., activity, vocalizations) each rated on ordinal behaviorally anchored scales. Total scores on the measure range from 23 to 100, with higher scores indicating higher child anxiety at induction. The tool has shown good convergent validity with another measure of child anxiety (r = 0.79), and excellent inter-rater reliability (kappa range 0.63-0.90). A cutoff score of 30 has been shown to have the best balance of sensitivity (0.85) and specificity (0.92). NOTE: Most of the measure is administered post-treatment, but part of it begins pre-treatment at baseline.

次要结局

未报告次要终点

研究者

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

Patrick J. McGrath

Supervisor

IWK Health Centre

研究点 (2)

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