Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

• State-Trait Anxiety Inventory (STAI) Score [Срок оценки: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy]
• Psychological Well-Being Scale Score [Срок оценки: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy]
• Family Satisfaction in the Intensive Care Unit-24 (FS-ICU-24) Score [Срок оценки: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Giresun Training and Research Hospital — Giresun

Идентификаторы

NCT: NCT07737353 · TRACH-FAMILY-2026-01 · 15.04.2026/08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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