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临床试验/NCT05902052
NCT05902052已完成不适用

Master of Science, Registery Nurse

Kutahya Health Sciences University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Type of analgesic

研究概览

简要总结

Open heart surgery method is generally used in the treatment of cardiovascular diseases. Sternotomy is the process of opening the sternum. After sternotomy, individuals experience ongoing pain in the anterior thorax. Despite developing pain methods and treatments, individuals undergoing cardiovascular surgery suffer from pain that cannot be managed well. Patients undergoing cardiac surgery experience severe pain for the first 48 hours and are in intensive care during this period. Pain is the most important stress factor for intensive care patients. The nurse and health care team should play a key role and take an active role in the management and evaluation of pain. However, there are not enough studies trying to define the role of the nurse in the management of postoperative pain. Protocols are used to provide pain management and routine pain assessment in intensive care units. The use of protocols provides maximum care to the patient, while reducing the cost. It also ensures the patient's participation in the treatment. While protocols ensure that practices are converted into evidence-based ones, they also prevent disruptions in treatment. As a result, management of the pain experiences of patients with sternotomy who underwent open heart surgery in the intensive care unit with the developed protocol; It will guide the improvement and development of pain management. It is thought that the protocol will address the pain of individuals undergoing open heart surgery in a holistic way. In addition, no study has been found in the literature that includes the development of a protocol for the pain of intensive care patients undergoing open heart surgery. For this reason, it is thought that the study will shed light on the literature by being a resource in the management and improvement of pain.

详细描述

In this study, it is aimed to develop the open heart surgery patient care protocol and to examine its effect on the pain that develops after sternotomy. The research is planned to be carried out on the patients in the Cardiovascular Surgery Intensive Care Unit of Research Hospital. The sample size of this study was decided by power analysis. The G-Power statistics program is based on Type 1 error 0.05 and 80% power. In the power analysis of Akbayrak and Tosun's (2002) thesis study, using the results showing the average score of the satisfaction level of the patients with and without the care protocol, the sample size was determined as 17 patients for each group and 34 patients in total. However, in order to meet the parametric test assumptions, it was decided to include at least 30 people in each group.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with sternotomy who underwent Coronary Artery Bypass Graft surgery,
  • Patient with sternotomy who underwent valve surgery,
  • Being 18 years or older,
  • Volunteering to participate in the research,
  • Being at a level to adequately answer the questions asked cognitively,
  • Experiencing pain at least once after the surgery,
  • No complications (unable to wean from mechanical ventilator support, inability to discontinue inotropic support) until the period of transfer to the postoperative service.

排除标准

  • Desiring to leave the study group during the conduct of the research,
  • Delirium development in the patient during the conduct of the study,
  • The patient for whom emergency surgery has been decided.

结局指标

主要结局

Type of analgesic

时间窗: 3 days

Type of analgesic

Visual Analog Scale

时间窗: 3 days

Visual Analog Scale

Scale for Evaluation of the Quality of Care Given to the Patient in Relief of Postoperative Pain

时间窗: Just before being transferred to intensive care

The scale consists of 14 items and has 3 sub-dimensions related to nursing interventions, pain management and environment. Likert type scale was used in the evaluation. 1 means "strongly disagree" and 5 means "strongly agree". The scale Cronbach's coefficient was 0.81 and the main score obtained from the scale was 45.8 ± 10.8. The scale is a reliable and valid instrument in Turkish language.

Analgesic use

时间窗: 3 days

Number of analgesic use

次要结局

  • respiratory(3 days)
  • Anxiety(Before going into surgery, Just before being transferred to intensive care)
  • Blood pressure(3 days)
  • Fever(3 days)
  • Heart rate(3 days)
  • Oxygen Saturation(3 days)
  • Partial pressure of carbon dioxide(3 days)
  • Partial pressure of oxygen(3 days)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Necibe Dağcan

Lecturer

Kutahya Health Sciences University

研究点 (2)

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