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临床试验/NCT04796077
NCT04796077已完成不适用

Efficacy of an Educational Pop-Up Book in Preparing Children for Anesthesia: A Randomized Controlled Trial

Children's Healthcare of Atlanta2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2020年8月26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
148
试验地点
2
主要终点
Observer-Rated Behavioral Anxiety at Anesthesia Induction as assessed by the modified Yale Preoperative Anxiety Scale-Short Form

研究概览

简要总结

The study evaluated an educational pop-up book about general anesthesia induction as an interactive, child-focused preoperative education resource for pediatric patients undergoing outpatient surgery. The study's objectives were to evaluate the book as an educational tool and to understand the book's effects on patient and caregiver perceptions of the surgical experience. The study's hypotheses were that preoperative education from the pop-up book, compared to standard care, would more effectively reduce children's fear and expected pain, facilitate more positive views of the procedure and preoperative explanations, encourage adaptive coping strategies, reduce behavioral anxiety at anesthesia induction, and increase caregiver satisfaction with the surgical experience.

研究设计

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

盲法说明

An observer-rated behavioral anxiety outcome was masked (raters were blinded to patient group assignments). Other measures were patient self-report (unmasked).

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Observer-Rated Behavioral Anxiety at Anesthesia Induction as assessed by the modified Yale Preoperative Anxiety Scale-Short Form

时间窗: Baseline anxiety was rated upon initial entry into the preoperative holding area; anxiety at induction was rated while patients received inhalational induction via an anesthesia mask.

Patients' behavioral anxiety at anesthesia induction was assessed relative to baseline using the observer-rated modified Yale Preoperative Anxiety Scale-Short Form. The scale ranges from 22.92-100; higher scores indicate greater anxiety (worse outcomes). Raters were preoperative nurses and circulating nurses blinded to group assignments.

次要结局

  • Self-Reported Coping Strategies for Managing the Stress of Anesthesia Induction(Patients were interviewed after education and before premedication was administered.)
  • Caregiver Satisfaction with the Surgical Experience as assessed by a Likert-Scale Questionnaire(The questionnaire was administered after the patient underwent anesthesia induction.)
  • Expectations about the Procedure, Attitudes about Anesthesia, and Views of Preoperative Explanations as assessed by a Likert-Scale Questionnaire(The outcomes were rated after education and before premedication was administered.)
  • Fear of Anesthesia Induction as assessed by the Children's Fear Scale(Fear was rated after education and before premedication was administered.)
  • Expected Pain from the Anesthesia Mask and During Surgery as assessed by the Faces Pain Scale-Revised(Expected pain was rated after education and before premedication was administered.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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