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临床试验/NCT02755909
NCT02755909已完成不适用

The Effect of Pre-anesthetic Education on Patients' Anxiety Level Undergoing Cardiac Surgery

Indonesia University0 个研究点目标入组 36 人开始时间: 2015年12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
36
主要终点
Subjects' Anxiety Level before Education

研究概览

简要总结

The study aims to investigate the effect of pre-anesthetic education on patients undergoing cardiac surgery

详细描述

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Subjects identification was done using identification form, medical record, Mini Mental State Evaluation (MMSE) and Internal Classification of Diseases (ICD) 10. Subjects' anxiety level were measured using Amsterdam Preoperative Anxiety and Information Scale (APAIS) with the help of the researcher to explain the questions. Then, education were given to the subjects, guided by a flow chart made by the researcher, using verbal and emphatic non-verbal language. If during education subjects got anxious with or without cardiovascular emergencies, education would be stopped, subjects would be eased down. Subject's family would be called in. If the subjects agreed to continue, the study would be carried on, otherwise subjects were dropped out. Benzodiazepin and midazolam 0.5 mg/kgBW would be considered and consulted to a psychiatrist. On the day after the education and discussion, subjects filled in APAIS again before entering the operation room. APAIS score recorded before and after anesthesia would be presented in the means, and analyzed by SPSS using paired T-test (or Wilcoxon test as the alternative test).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 18-65 years old
  • Subjects able to read and write properly
  • Subjects have adequate communication ability
  • Subjects were able to speak Indonesian language properly
  • Subjects were planned to undergo cardiac surgery
  • Subjects have given informed consent for the anesthetical and surgical procedures.

排除标准

  • Subjects who did not give informed consent
  • Subjects who had done a cardiac surgery before this study commenced,
  • Subjects who had a cognitive/psychiatric problem that decreased communication ability
  • Subjects in antianxiety and/or antidepressant treatment.
  • Drop out criteria:
  • Subjects who had anxiety sign and symptoms with/without cardiovascular alarming signs and could not be eased down during education
  • Subjects decided to drop out the study.

结局指标

主要结局

Subjects' Anxiety Level before Education

时间窗: 2 months

Subjects' anxiety level before education was measure using APAIS instrument.

Subjects' Anxiety Level after Education

时间窗: 2 months

Subjects' anxiety level after education was measure using APAIS instrument.

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

Arif H. M. Marsaban

Consultant, Anesthesiologist

Indonesia University

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