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

NCT07737353 | Recruiting

• 2 other identifiers: TRACH-FAMILY-2026-0115.04.2026/08
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Tracheostomy; Critical Illness; Intensive Care

Keywords

Structured Education; Family Members; Intensive Care Unit; Tracheostomy; Anxiety; Psychological Well-Being; Satisfaction With Care; Family-Centered Care; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy

Study Arms (2)

Structured Education Group

EXPERIMENTAL

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 Group

ACTIVE 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

Interventions

Structured Education Program BEHAVIORAL

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.

Structured Education Group

Routine Information OTHER

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.

Routine Information Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun Training and Research Hospital

Giresun, Giresun, 28200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Critical Illness; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): May 18, 2027
• Study Completion (Estimated): May 18, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

TU (1)