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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
84
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.
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.
Giresun Training and Research Hospital
Giresun, Giresun, Turkey (Türkiye)
RECRUITINGState-Trait Anxiety Inventory (STAI) Score
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.
Time frame: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
Psychological Well-Being Scale Score
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.
Time frame: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
Family Satisfaction in the Intensive Care Unit-24 (FS-ICU-24) Score
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.
Time frame: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
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