Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGiresun University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Education Program
BehavioralThe 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.
Routine Information
Other interventionParticipants 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Structured Education GroupExperimental treatment 1 intervention
Group B: Routine Information GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
State-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 tracheostomy2
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 tracheostomy3
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 tracheostomySponsors and contacts
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Source ClinicalTrials.gov