The Effect of Therapeutic Approach-Based Education on Intubation and Agitation in Open-Heart Surgery Patients: A Randomized Controlled Trial

Research Hypotheses
H-1: The intubation responses of patients in the experimental group who received pre- and post-operative education
will differ from those of patients in the control group.
H-1-1: The intubation responses of patients in the experimental group who received pre- and post-operative education
will be less than those of patients in the control group.
H-2: The agitation behaviours of patients in the experimental group who received pre- and post-operative education, as measured by the RASS scale,
will differ from those of patients in the control group.
H-2-1: The agitation behaviours of patients in the experimental group who received pre- and post-operative education, as measured by the RASS scale,
will be less than those of patients in the control group.
H-3: The intubation time of the experimental group patients who received pre- and post-surgery education will be different from that of the control group patients.
H-3-1: The intubation time of the experimental group patients who received pre- and post-surgery education will be shorter than that of the control group patients.

Place and Time of the Research
The study was conducted between 10 October 2022 and 7 January 2023 at a foundation university hospital in Istanbul, in the intensive care unit and inpatient ward of the Department of Cardiovascular Surgery.

All participants completed a sociodemographic information form and a numerical anxiety scale before surgery. Four hours after awakening, the researcher completed the RASS and Intubation Response Form for all participants and recorded the duration of intubation.

Differences in the proportions of categorical variables between independent groups were analysed using the Chi-square and Fisher's exact tests. Differences in continuous variables between groups were analysed using the independent groups t-test.
The experimental and control groups were determined to be homogeneous in terms of sampling. When analysed, the intubation responses of the experimental and control groups showed significant differences in terms of wrinkled facial expression and blanket-pulling response.
No differences were observed between the groups in terms of other parameters. A statistically significant difference was found between the experimental and control groups in terms of the wrinkled facial expression response (X² = 5.000; p = 0.030 < 0.05). The percentage of participants exhibiting a wrinkled facial expression in the control group (80.0%) was higher than that in the experimental group (40.0%). A significant difference was also found between the groups in terms of the response of gathering the sheet with their hands (X² = 6.652; p = 0.013 < 0.05). The rate of this response in the control group (66.7%) was higher than that in the experimental group (20.0%). The results indicate that the control group exhibited these two behavioural responses more frequently than the experimental group.

研究假设
H-1：接受术前及术后教育的实验组患者的插管反应，将与对照组患者存在差异。
H-1-1：接受术前及术后教育的实验组患者的插管反应，将弱于对照组患者。
H-2：接受术前及术后教育的实验组患者的躁动行为，经里奇蒙躁动-镇静评分（RASS，Richmond Agitation-Sedation Scale）评估后，将与对照组患者存在差异。
H-2-1：接受术前及术后教育的实验组患者的躁动行为，经里奇蒙躁动-镇静评分（RASS，Richmond Agitation-Sedation Scale）评估后，将弱于对照组患者。
H-3：接受术前及术后教育的实验组患者的插管时长，将与对照组患者存在差异。
H-3-1：接受术前及术后教育的实验组患者的插管时长，将短于对照组患者。

研究开展地点与时间
本研究于2022年10月10日至2023年1月7日期间，在土耳其伊斯坦布尔的一所基金会资助的大学医院心血管外科重症监护室与住院病房开展。

所有受试者均在术前填写社会人口学信息量表与数字焦虑量表。受试者苏醒后4小时，研究者为所有受试者完成里奇蒙躁动-镇静评分（RASS）与插管反应量表评估，并记录插管持续时长。

组间分类变量的比例差异采用卡方检验与费希尔精确检验进行分析；组间连续变量的差异采用独立样本t检验进行分析。

经抽样验证，实验组与对照组基线特征齐同。分析结果显示，实验组与对照组的插管反应在面部皱缩表情与拉扯床单反应两项指标上存在显著差异，其余参数未观察到组间差异。实验组与对照组在面部皱缩表情反应上存在统计学显著性差异（χ²=5.000；p=0.030<0.05），对照组出现该反应的受试者占比（80.0%）高于实验组（40.0%）。两组在双手拉扯床单的反应上同样存在统计学显著性差异（χ²=6.652；p=0.013<0.05），对照组该反应的发生率（66.7%）高于实验组（20.0%）。上述结果表明，对照组出现上述两种行为反应的频率显著高于实验组。