Critical Illness, Intensive Care, Tracheostomy
Conditions
Keywords
Structured Education, Family Members, Intensive Care Unit, Tracheostomy, Anxiety, Psychological Well-Being, Satisfaction With Care, Family-Centered Care, Randomized Controlled Trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStructured 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.
OTHERRoutine 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.
Sponsors
Giresun University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A total of 84 family members of patients undergoing tracheostomy in the intensive care unit will be randomly assigned in a 1:1 ratio to either the structured education group or the routine care group. Outcomes will be assessed at baseline, on the first day after tracheostomy, and one week after the procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory (STAI) Score | 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. |
| Psychological Well-Being Scale Score | 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. |
| Family Satisfaction in the Intensive Care Unit-24 (FS-ICU-24) Score | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed