跳至主要内容
临床试验/NCT06174974
NCT06174974招募中不适用

The Effect of Education Given to Patients Before Cardiac Surgery on Environmental Stressors Perceived by the Patient: A Randomised Controlled Study

Trakya University2 个研究点 分布在 1 个国家目标入组 64 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
招募中
入组人数
64
试验地点
2
主要终点
environmental stressors perceived by patients

研究概览

简要总结

Aim of the Thesis and Hypotheses: (The aim of the thesis and hypotheses should be stated in detail.) In this study, it was aimed to determine the effect of the education given to the patients before cardiac surgery on the environmental stressors perceived by the patients in the intensive care unit.

H1: The education given before heart surgery has an effect on the environmental stressors perceived by patients in the intensive care unit.

H2: The education given before cardiac surgery has no effect on the environmental stressors perceived by patients in the intensive care unit.

详细描述

The randomised controlled trial will be conducted in the cardiovascular surgery service of Trakya University Health Research and Application Centre. Date of research will be conducted: November.2023- March 2024 The research sample will consist of 64 volunteer patients. The sample was determined using power analysis at the research planning stage. The minimum number of people to be included in the sample was calculated as 54, each group consisting of 27 (1:1) patients, with an effect size of 0.80, 95% confidence level, 5% tolerance and 80% power ratio, using the G.Power 3.1.9.4 programme. In case of possible patient loss, the sample size was increased by 20% and each group was decided to consist of 32 patients. A total of 64 patients were included in the sample.

Data Collection Forms Patient information form; The form was developed by the researchers in line with the literature and includes some characteristics (age, gender, educational status, marital status, habits, surgical experience, presence of preoperative stress, physician diagnosis, surgical procedure performed, presence of chronic disease, presence of companion, presence of intensive care experience, perception of intensive care experience, opinion about the concept of intensive care, presence of anxiety about intensive care follow-up, postoperative hospitalisation day in the intensive care unit).

Intensive Care Unit Environmental Stressors Scale; This scale was developed by Ballard (1) in 1981 to describe the stressors perceived by patients treated in intensive care units and revised by Cochran and Ganong (2) in 1989. The scale was adapted into Turkish by Çınar, Aslan and Kurtoğlu (3) and Cronbach's alpha value was found to be 0.94. The scale contains 42 items and the answers are in 4-point Likert type. 1=Never affects, 2= Very little affects, 3= Frequently affects, 4= Very much affects. The lowest total score of the scale is 42 points and the highest is 168 points.

Patient satisfaction form; The satisfaction of the patients in the experimental group with the preoperative training will be evaluated with a numerical rating scale ranging from 0 to 10 points (0 = Not at all satisfied, 10 = Very satisfied).

Data Collection Process The researcher will visit the service and identify the patients who will undergo cardiac surgery. Before starting data collection, the eligibility of the patients will be determined based on the sampling criteria. Patients who meet the inclusion criteria will be informed verbally and in writing about the research, scales, etc. in the preoperative period and the informed consent form will be signed. "Patient Information Form" will be applied in the preoperative period. The data of the study will be collected by the researcher in the patient room by face-to-face interview method.

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
Single (Outcomes Assessor)

盲法说明

The data will be collected and coded by the nurse researcher. Data will be analyzed by an independent statistician. The study groups will be disguised as A and B. The statistician will not know the groups. In addition, the statistical expert will not see the data of the experimental group regarding satisfaction.

入排标准

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

入选标准

  • Inpatient treatment in the cardiovascular surgery ward prior to surgery,
  • Undergoing planned cardiac surgery under general anaesthesia,
  • Admitted to the cardiovascular surgery intensive care unit after surgery,
  • At least 24 hours in the intensive care unit,
  • Sternotomy performed,
  • who volunteered to participate in the research,
  • No mental disability,
  • 18 years of age,
  • Literate,
  • Accepting random selection,
  • Patients without communication problems in Turkish

排除标准

  • Treated as a day patient in the cardiovascular surgery ward,
  • Pre-operative inpatient treatment in cardiology, coronary intensive care or other external wards,
  • Without sternotomy,
  • Admitted to intensive care or external ward after surgery,
  • Emergency surgery,
  • Not volunteering to participate in the research,
  • Mentally handicapped,
  • Under 18 years of age,
  • Illiterate,
  • which does not accept random selection,
  • Patients with communication problems in Turkish

结局指标

主要结局

environmental stressors perceived by patients

时间窗: Patients transferred from the cardiovascular surgery intensive care unit to the cardiovascular surgery service, on the day of transfer (postoperative 2-3rd day).

To determine the effect of education given before cardiac surgery on environmental stressors perceived by patients in the intensive care unit."Intensive Care Unit Environmental Stressors Scale" will be applied on the day the patients are transferred to the ward. The 4-Likert type scale consists of 42 items. The items evaluated as "It does not affect at all (1 point) ", "It affects very little (2 points)", "It frequently affects (3 points)" and "It affects too much (4 points)". The lowest total score is 42 and the highest total score is 168. The high score obtained from the scale indicates that there are many environmental stressors in the intensive care environment, and they negatively affect the patients.

次要结局

  • patients' satisfaction(postoperative period (postoperative 2nd or 3rd day))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Kızılcık Ozkan

Assistant professor

Trakya University

研究点 (2)

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