此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy (TRACH-FAMILY)

2026年7月27日 更新者：Alkay Kara、Giresun University

The Effect of Structured Education Provided to Family Members of Patients Undergoing Tracheostomy in the Intensive Care Unit on Anxiety, Psychological Well-Being, and Satisfaction With Care: A Randomized Controlled Trial

Family members of patients undergoing tracheostomy in the intensive care unit frequently experience anxiety, uncertainty, and concerns regarding the patient's care. This randomized controlled trial aims to evaluate the effect of structured education provided to family members of patients undergoing tracheostomy in the intensive care unit on state anxiety, psychological well-being, and satisfaction with care. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive structured education before tracheostomy, whereas the control group will receive routine information. Outcomes will be assessed before tracheostomy, on the first day after tracheostomy, and one week after the procedure.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This prospective, parallel-group, randomized controlled trial is designed to evaluate the effect of structured education provided to family members of patients undergoing tracheostomy in the intensive care unit on state anxiety, psychological well-being, and satisfaction with care. The study is being conducted in the intensive care unit of Giresun Training and Research Hospital. A total of 84 eligible family members will be randomly assigned in a 1:1 ratio to either the intervention or control group.

Participants in the intervention group will receive a structured face-to-face educational program developed by the research team before the tracheostomy procedure. The educational program includes information on the purpose of tracheostomy, the procedure, potential risks, intensive care management, communication with the patient, post-discharge care, and the role of family members in the care process. Participants in the control group will receive routine information provided according to the standard clinical practice of the hospital.

The primary outcomes are state anxiety, psychological well-being, and satisfaction with care. Trait anxiety will also be assessed at baseline. Outcome assessments will be performed before tracheostomy (baseline), on the first day after the procedure, and one week after tracheostomy. The findings are expected to provide evidence regarding the effectiveness of structured educational interventions for family members of critically ill patients and contribute to improving family-centered care in intensive care units.

研究类型

介入性

注册 (估计的)

84

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Giresun
      • Giresun、Giresun、土耳其（türkiye）、28200
        • 招聘中
        • Giresun Training and Research Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Family member or primary caregiver of a patient scheduled to undergo tracheostomy in one of the participating intensive care units.
  • Aged 18 years or older.
  • Able to read, understand, and communicate in Turkish.
  • Willing to participate in the study.
  • Provides written informed consent.
  • Actively involved in the patient's care and treatment process.

Exclusion Criteria:

  • Diagnosed with a severe psychiatric disorder.
  • Severe hearing, visual, or cognitive impairment that prevents completion of the study questionnaires.
  • Communication problems that prevent participation in the data collection process.
  • Declines to participate in the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Structured Education Group
Participants in this group will receive a structured face-to-face educational program developed by the researchers before the patient undergoes tracheostomy. The education will include information about the purpose of tracheostomy, the procedure, post-tracheostomy care, communication with the patient, potential problems, and the role of family members in the care process.
行为的：Structured Education Program
The structured education will be delivered face-to-face to the family member before the patient undergoes tracheostomy. The program will cover the purpose and necessity of tracheostomy, the procedure, changes that may occur after tracheostomy, communication methods, basic care principles, potential complications, and the involvement of family members in the care process. Participants' questions will be addressed during the educational session.
有源比较器：Routine Information Group
Participants in this group will receive routine verbal information provided by healthcare professionals as part of the standard clinical practices of the intensive care unit. The structured educational program developed by the researchers will not be provided to this group.
其他：Routine Information
Participants will receive routine verbal information provided by healthcare professionals according to the standard clinical practice of the intensive care unit. No structured educational program will be provided.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
State-Trait Anxiety Inventory (STAI) Score
大体时间：Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). At baseline, both the State Anxiety and Trait Anxiety subscales will be administered. At 1 day and 1 week after tracheostomy, only the State Anxiety subscale will be administered. Each subscale ranges from 20 to 80, with higher scores indicating higher levels of anxiety.
Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
Psychological Well-Being Scale Score
大体时间：Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
Psychological well-being will be assessed using the 8-item Psychological Well-Being Scale. Each item is scored from 1 to 7, resulting in a total score ranging from 8 to 56. Higher scores indicate greater psychological well-being.
Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
Family Satisfaction in the Intensive Care Unit-24 (FS-ICU-24) Score
大体时间：Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
Family satisfaction will be assessed using the 24-item Family Satisfaction in the Intensive Care Unit questionnaire (FS-ICU-24). The questionnaire evaluates satisfaction with care, information, and participation in decision-making. Each item is scored from 1 to 5. Higher scores indicate greater family satisfaction with intensive care.
Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Giresun University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月18日

初级完成 (估计的)

2027年5月18日

研究完成 (估计的)

2027年5月18日

研究注册日期

首次提交

2026年7月27日

首先提交符合 QC 标准的

2026年7月27日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TRACH-FAMILY-2026-01
  • 15.04.2026/08 (其他标识符：Medical Research Ethics Committee, Giresun University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅