Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy (TRACH-FAMILY)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Giresun
-
Giresun, Giresun, Tyrkiet (Türkiye), 28200
- Rekruttering
- Giresun Training and Research Hospital
-
Kontakt:
- ALKAY KARA, PhD
- Telefonnummer: +90 539 441 64 97
- E-mail: alkay@outlook.com.tr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Structured Education Group
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.
|
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.
|
|
Aktiv komparator: Routine Information Group
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
State-Trait Anxiety Inventory (STAI) Score
Tidsramme: 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.
|
Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
|
|
Psychological Well-Being Scale Score
Tidsramme: 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.
|
Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
|
|
Family Satisfaction in the Intensive Care Unit-24 (FS-ICU-24) Score
Tidsramme: 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.
|
Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TRACH-FAMILY-2026-01
- 15.04.2026/08 (Anden identifikator: Medical Research Ethics Committee, Giresun University)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .