Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy | NCT07737353

NCT07737353

Overview

NCT ID: NCT07737353
Lead Sponsor: Giresun UniversityOTHER
Official Title: 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
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.
Conditions

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: May 18, 2026Actual
Primary Completion Date: May 18, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 84Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Giresun Training and Research Hospital

Similar Studies

Participant Group/Arms

Structured Education GroupExperimental

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.

Behavioral: Structured Education Program

Routine Information GroupActive Comparator

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.

Other: Routine Information