跳至主要内容
临床试验/NCT05143580
NCT05143580Unknown不适用

Preoperative Cognitive Therapy Intervention in Reducing Delirium After Cardiac Surgery

Changhua Christian Hospital0 个研究点目标入组 120 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
Severity of delirium

研究概览

简要总结

This research is designed for experimental quantitative research and is conducted by simple random sampling. Both the control group and the experimental group provided preoperative routine nursing treatment and preoperative medical teaching manuals. The latter adds cognitive therapy and gamification evaluation. Both groups used CAM-ICU to assess the occurrence and duration of postoperative delirium, and DRS-R-98 was used to assess the severity of delirium. After collection, use SPSS 22.0 statistical software package for analysis and processing. The expected result is that the incidence of delirium, the duration of delirium, and the severity of delirium in the experimental group were significantly lower than those in the control group.

详细描述

This study is an experimental quantitative research design. Both the control group and the experimental group provide routine nursing treatment and preoperative medical teaching manuals before surgery. The latter adds cognitive therapy and gamification evaluation of "Postoperative Care and Environmental Image Data Explanation". The two groups used CAM-ICU to assess the occurrence and duration of delirium after surgery, and DRS-R-98 was used to assess the severity of delirium. From 2021 to 2022, a simple random sampling method is adopted for patients undergoing cardiac surgery in the intensive care unit of a medical center in Central Taiwan, and a lottery is drawn on the first day of each month to determine the belong to which group in the current month. There were 55 persons in each group, and all subjects had no cognitive impairment. After the collected, it was analyzed and processed with SPSS 22.0 statistical package software.

Expected results: The incidence of delirium, the duration of delirium, and the severity of delirium in the experimental group were significantly lower than the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery.
  • No cognitive impairment before surgery.

排除标准

  • Diagnosed with aortic dissection.
  • Previously admitted to the intensive care unit.

结局指标

主要结局

Severity of delirium

时间窗: When delirium occurs, assessment is conducted at 9 am every day until the end of delirium, an average of one month.

* When delirium occurs, use Delirium Rating Scale-Revised-98 (DRS-R-98) to score the severity of delirium symptoms. * DRS-R-98 has a total of 16 scoring items, including 13 delirium severity and 3 diagnosis items. The total score is up to 46 points, of which the highest severity is 39 points. The higher the score, the more serious. * Clinically, the total score ≥ 18 points or the severity score ≥ 15 points are used.

Duration of delirium

时间窗: Completed through delirium, an average of one month.

- When using the CAM-ICU assessment system, delirium occurs, and the time from the occurrence to the end of the delirium will be recorded.

Incidence of delirium

时间窗: After surgery, the patient was evaluated at 48 hours.

* First use the Richmond Restlessness and Sedation Scale (RASS) to assess the state of consciousness. RASS is a 10-point scale. +1 to +4 represent different levels of anxiety, 0 points represent alertness and calmness, and -1 to -5 represent different levels of sedation. * When the RASS score is between -3 and +4, then evaluate the Confusion Assessment Method for the intensive care unit (CAM-ICU). The CAM-ICU is a four-step assessment method with items on altered mental status or fluctuating course, inattention, and altered level of consciousness or disorganized thinking. * If the evaluation result is the following two combinations, the first combination is mental state change, inattention, and consciousness level change; the second combination is mental state change, inattention, and disorganized thinking. This means that the CAM-ICU is positive and delirium has occurred.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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