TracheostomyTRACH-FAMILYNCT07737353
Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy
A study testing Structured Education Program and Routine Information in people with Tracheostomy and Critical Illness, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Critical Illness, Intensive Care
- What is being tested?
- Structured Education Program and Routine Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2026to 18 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Giresun Training and Research Hospital
Giresun, Giresun, 28200
ALKAY KARA, PhD, +90 539 441 64 97, alkay@outlook.com.tr
About this study
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
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.
Read the 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.
- Conditions
- Tracheostomy, Critical Illness, Intensive Care
- Being tested
- Structured Education Program, Routine Information
- Keywords
- Structured Education, Family Members, Intensive Care Unit, Tracheostomy, Anxiety, Psychological Well-Being, Satisfaction With Care, Family-Centered Care, Randomized Controlled Trial
- Medical subject headings
- Critical Illness, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Education ProgramBehavioural
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.
Routine InformationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start18 May 2026
- Primary completion18 May 2027 (estimated)
- Study completion18 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alkay Kara, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737353
- Sponsor's protocol ID
- TRACH-FAMILY-2026-01
- Other IDs
- 15.04.2026/08
- Acronym
- TRACH-FAMILY
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07737353
- Acronym / sponsor ID
- TRACH-FAMILY / TRACH-FAMILY-2026-01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 18 May 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Structured Education Group | Experimental | Behavioral: Structured Education ProgramParticipants 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. |
| Routine Information Group | Active comparator | Other: Routine InformationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Education ProgramThe 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. | Behavioural | Structured Education Group |
| Routine InformationParticipants 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. | Other | Routine Information Group |
Primary outcome
State-Trait Anxiety Inventory (STAI) Score
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giresun Training and Research Hospital
Giresun, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Education Program and Routine Information in people with Tracheostomy and Critical Illness, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) Score (time frame: Baseline before tracheostomy, 1 day after tracheostomy, and 1 week after tracheostomy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.