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临床试验/NCT07366021
NCT07366021进行中(未招募)不适用

The Effect of Comfort Care Packages Applied to Intensive Care Patients on Patients' Comfort Level and Physiological Parameters

Akdeniz University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
88
试验地点
1
主要终点
The Comfort Behaviors Checklist

研究概览

简要总结

Intensive care units (ICUs) are specialized units where numerous complex treatment and care procedures are applied. In these units, critically ill patients are exposed to stressful conditions and experience significant pain and other discomforts stemming from multiple internal and external factors that can alter their quality of life and trigger symptoms of post-traumatic stress disorder (PTSD). These discomforts can have various short-term or long-term consequences for patients after discharge from the ICU, such as anxiety and/or depression or PTSD, which can affect their quality of life. Therefore, knowing the negative factors affecting patient comfort in the ICU, as well as measuring patient comfort and eliminating or reducing these factors through comfort care, is crucial in reducing morbidity and mortality rates in patients. It is noteworthy that there is no specific care package in the literature aimed at improving ICU-specific comfort. Accordingly, this study aims to develop a "Comfort Care Package" to improve the comfort level of ICU patients. The research population will consist of all patients aged 18-65 years admitted to the intensive care units of Bursa City Hospital. This study will test the effect of the developed "Comfort Care Package" on the comfort level and physiological parameters of 88 ICU patients (control group=44 and study group=44) who meet the inclusion criteria and whose data were calculated using the G*Power 3.1 program. The study will begin with the collection of data from the control group. This group will receive routine ICU care. The study group will receive the Comfort Care Package. It is anticipated that the ICU-specific comfort care package developed within the scope of this study will make significant contributions to the creation of nursing care plans aimed at increasing the comfort levels of critically ill individuals. Therefore, in patients with improved comfort, targeted recovery outcomes may increase, mortality rates may decrease, and thus public health may be sustained.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Staying in the intensive care unit for at least 48 hours
  • Communication language being Turkish
  • For non-intubated patients, GCS > 12; for intubated patients, GCS > 10 + intubated (verbal response)

排除标准

  • Hearing and hearing problems
  • History or diagnosis of cognitive impairment, mental illness, nervous system disorders, brain injury
  • RASS score >1
  • Admitted with a diagnosis of alcohol/drug intoxication
  • Hemodynamically unstable patients receiving high-dose inotropic/vasopressor drug therapy
  • Transfer to another ICU
  • Emergency discharge from the ICU for any reason

研究组 & 干预措施

Intervention-Behavioral

Experimental

Comfort Care Bundle Contents:

  • Ensure and maintain Physical Comfort (Prevent and manage pain, support daily living activities)
  • Ensure and maintain Psychospiritual Comfort (Manage agitation-sedation and delirium)
  • Ensure and maintain Environmental Comfort (Arrange the environment to facilitate the patient's adaptation)
  • Ensure and maintain Sociocultural Comfort (Enable and maintain the patient's interaction with their environment, ensure family participation in care)

干预措施: Comfort Care Bundle (Behavioral)

Routine ICU care group

No Intervention

To avoid negatively impacting the data collection environment in the research (preventing issues such as bias by the nurse performing the procedure, ethical dilemmas, etc.), the study will begin with the collection of data from a control group. The control group will receive routine nursing care from the clinic.

结局指标

主要结局

The Comfort Behaviors Checklist

时间窗: O. Day and 7. Day

The Comfort Behaviors Checklist consists of 30 behavioral indicators. In addition, Kolcaba suggests that if listening comfort is the sole measurement tool, the individual should digitally score their pain and comfort, and that comfort should also be evaluated using a lens. Listening is coded in 42 different ways: 2, 3, 5, 7, 8, 9, 11, 12, 13, 19, 20, 21, 22, 24, 25, 27. The list is scored on a 4-point Likert scale. Parts of the list that are unsuitable for people are listed with a score of 0. The total number of questions answered is multiplied by 4 to obtain the possible score. The terminology questions are translated, and the scores of all questions are taken into account to obtain the raw comfort score. Finally, the possible comfort scores are divided by the raw scores to obtain a decimal number. The decimal part of the resulting score is expressed as a two-digit number. Higher scores indicate a high level of comfort.

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

Banu Terzi

Dr.

Akdeniz University

研究点 (1)

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