Intensive Care Unit (ICU) AdmissionNCT07435896
Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families
An observational study of Intensive Care Unit (ICU) Admission and Tracheostomy, run by Elazıg Fethi Sekin Sehir Hastanesi.
Trial summary
Decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) in the intensive care unit (ICU) are frequently associated with substantial uncertainty, decisional conflict, and psychosocial burden among patients' relatives. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit (ICU) Admission, Tracheostomy, Percutaneous Endoscopic Gastrostomy (PEG)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 15 Jun 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: First-degree relatives of adult ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) at Elazığ Fethi Sekin City Hospital. Participants are individuals directly involved in the medical decision-making process and responsible for providing consent for the procedures.
Who may be able to join
- First-degree relative of an ICU patient with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG)
- Age ≥ 18 years
- Able to understand and communicate in Turkish
- Provides written informed consent
- Responsible for or involved in the medical decision-making process
Who cannot join
- Cognitive impairment or psychiatric condition interfering with questionnaire completion
- Refusal to participate
- Prior participation in this study
- Inability to complete study questionnaires
About this study
Official title: Impact of Information and Participation Strategies on Decision Time for Tracheostomy or PEG Among Family Members of Intensive Care Patients
Decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) in the intensive care unit (ICU) are frequently associated with substantial uncertainty, decisional conflict, and psychosocial burden among patients' relatives. Inadequate or non-tailored information may negatively influence anxiety levels, decision satisfaction, and subsequent adaptation to care responsibilities. Differences in communication patterns and educational background may further affect how families perceive the risks, benefits, and long-term implications of these procedures.
This prospective study aims to evaluate the impact of relatives' educational level and different information delivery methods on anxiety, decision satisfaction, and the overall decision-making process related to tracheostomy and PEG in the ICU setting. The findings are expected to contribute to the development of structured, education-level-tailored information strategies to improve shared decision-making and family-centered care in critical care practice.
Read the detailed description
In the intensive care unit (ICU), decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) create substantial uncertainty and psychosocial burden for patients' relatives. The literature reports that decisional conflict and regret are common in the tracheostomy decision-making process; one of the principal contributing factors is inadequate information provided to patients and their families. Furthermore, the lack of standardized and effective education regarding tracheostomy care negatively affects families' coping capacity and quality of life.
Differences in communication and perspectives between family members and the healthcare team significantly influence decision satisfaction and the alignment of expectations, underscoring the importance of structured information and counseling strategies. Evidence from tracheostomy care and education studies also indicates that increased knowledge levels are associated with improved caregiving skills and better psychosocial adaptation.
In addition, the literature suggests that tracheostomy decisions are perceived variably by families in terms of both benefits and potential adverse consequences, and that satisfaction levels differ according to individual expectations and the extent of information received. Therefore, it is necessary to systematically investigate the impact of relatives' educational level and different information delivery methods on the decision-making process.
This prospective study aims to evaluate the effects of relatives' educational level and information strategies on anxiety levels, satisfaction, and decision-making processes related to tracheostomy and PEG in the ICU setting.
- Conditions
- Intensive Care Unit (ICU) Admission, Tracheostomy, Percutaneous Endoscopic Gastrostomy (PEG)
- Keywords
- Percutaneous Endoscopic Gastrostomy, Tracheostomy, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group E1 | includes first-degree relatives of ICU patients indicated for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of primary school or below. | |
| Group E2 | includes first-degree relatives of ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of secondary school or high school. | |
| Group E3 | includes first-degree relatives of ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of university degree or higher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score
Anxiety levels of first-degree relatives will be assessed before and after the standardized information process using the Hospital Anxiety and Depression Scale (HADS), Turkish validated version.
The HADS consists of 14 items, with the Anxiety subscale (HADS-A) comprising 7 items. The HADS-Anxiety subscale score ranges from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome).
The primary endpoint will be the change in HADS-Anxiety subscale score, calculated as post-information score minus pre-information score.
Measured: Immediately before information delivery and immediately after completion of the information session (same day).
Secondary outcomes (3)
Mean Total Score of the Family Satisfaction in the Intensive Care Unit Questionnaire (FS-ICU-24)
Family satisfaction regarding care and decision-making will be evaluated using the Turkish validated version of the Family Satisfaction in the Intensive Care Unit questionnaire (FS-ICU-24).
The FS-ICU-24 consists of 24 items assessing satisfaction with care and satisfaction with decision-making. Items are rated on a 5-point Likert scale and transformed to a 0-100 scale according to the standard scoring method, with higher scores indicating greater satisfaction (better outcome).
Domain scores will be combined to calculate a single total score (0-100 scale).
Measured: After completion of the decision-making process (within 24-48 hours following the information session).
Decision-Making Process Evaluation
Decision clarity, perceived participation in decision-making, and decisional conflict will be assessed using the decision-making domain of the Turkish validated version of the Family Satisfaction in the Intensive Care Unit questionnaire (FS-ICU-24).
The FS-ICU-24 consists of 24 items rated on a 5-point Likert scale and transformed to a 0-100 scale according to the standard scoring method, with higher scores indicating greater satisfaction and better perceived decision-making quality.
Mean domain scores will be calculated for each group and compared across educational levels and information methods.
Measured: Within 24-48 hours after the decision regarding tracheostomy and/or PEG.
Demographic and Clinical Variables
Patient and relative demographic and clinical data will be collected using a standardized data collection form for covariate analysis.
Measured: At enrollment (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit (ICU) AdmissionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435896
- Sponsor's protocol ID
- FSCH-SBÜ-2026/03 TPEG
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the single-center design of the study and the inclusion of sensitive psychosocial and decision-making data from patients' relatives. Although data will be analyzed in anonymized form, sharing individual-level data may pose potential risks to participant confidentiality. Aggregate results will be made publicly available through scientific publication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Information and Participation Strategies on Decision Time for Tracheostomy or PEG Among Family Members of Intensive Care Patients
- ClinicalTrials.gov ID
- NCT07435896
- Acronym / sponsor ID
- FSCH-SBÜ-2026/03 TPEG
- Conditions
- Intensive Care Unit (ICU) Admission, Tracheostomy, Percutaneous Endoscopic Gastrostomy (PEG)
- Keywords
- Percutaneous Endoscopic Gastrostomy, Tracheostomy, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 27 Feb 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.
Decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) in the intensive care unit (ICU) are frequently associated with substantial uncertainty, decisional conflict, and psychosocial burden among patients' relatives. Inadequate or non-tailored information may negatively influence anxiety levels, decision satisfaction, and subsequent adaptation to care responsibilities. Differences in communication patterns and educational background may further affect how families perceive the risks, benefits, and long-term implications of these procedures.
This prospective study aims to evaluate the impact of relatives' educational level and different information delivery methods on anxiety, decision satisfaction, and the overall decision-making process related to tracheostomy and PEG in the ICU setting. The findings are expected to contribute to the development of structured, education-level-tailored information strategies to improve shared decision-making and family-centered care in critical care practice.
Detailed description
In the intensive care unit (ICU), decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) create substantial uncertainty and psychosocial burden for patients' relatives. The literature reports that decisional conflict and regret are common in the tracheostomy decision-making process; one of the principal contributing factors is inadequate information provided to patients and their families. Furthermore, the lack of standardized and effective education regarding tracheostomy care negatively affects families' coping capacity and quality of life.
Differences in communication and perspectives between family members and the healthcare team significantly influence decision satisfaction and the alignment of expectations, underscoring the importance of structured information and counseling strategies. Evidence from tracheostomy care and education studies also indicates that increased knowledge levels are associated with improved caregiving skills and better psychosocial adaptation.
In addition, the literature suggests that tracheostomy decisions are perceived variably by families in terms of both benefits and potential adverse consequences, and that satisfaction levels differ according to individual expectations and the extent of information received. Therefore, it is necessary to systematically investigate the impact of relatives' educational level and different information delivery methods on the decision-making process.
This prospective study aims to evaluate the effects of relatives' educational level and information strategies on anxiety levels, satisfaction, and decision-making processes related to tracheostomy and PEG in the ICU setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group E1 | – | –includes first-degree relatives of ICU patients indicated for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of primary school or below. |
| Group E2 | – | –includes first-degree relatives of ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of secondary school or high school. |
| Group E3 | – | –includes first-degree relatives of ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) who have a self-reported educational level of university degree or higher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- First-degree relatives of adult ICU patients with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG) at Elazığ Fethi Sekin City Hospital. Participants are individuals directly involved in the medical decision-making process and responsible for providing consent for the procedures.
Key inclusion criteria (5 listed)
- First-degree relative of an ICU patient with an indication for tracheostomy and/or percutaneous endoscopic gastrostomy (PEG)
- Age ≥ 18 years
- Able to understand and communicate in Turkish
- Provides written informed consent
- Responsible for or involved in the medical decision-making process
Key exclusion criteria (4 listed)
- Cognitive impairment or psychiatric condition interfering with questionnaire completion
- Refusal to participate
- Prior participation in this study
- Inability to complete study questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score
Time frame: Immediately before information delivery and immediately after completion of the information session (same day).
Anxiety levels of first-degree relatives will be assessed before and after the standardized information process using the Hospital Anxiety and Depression Scale (HADS), Turkish validated version. The HADS consists of 14 items, with the Anxiety subscale (HADS-A) comprising 7 items. The HADS-Anxiety subscale score ranges from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome). The primary endpoint will be the change in HADS-Anxiety subscale score, calculated as post-information score minus pre-information score.
3 secondary outcomes
Mean Total Score of the Family Satisfaction in the Intensive Care Unit Questionnaire (FS-ICU-24)
Time frame: After completion of the decision-making process (within 24-48 hours following the information session).
Decision-Making Process Evaluation
Time frame: Within 24-48 hours after the decision regarding tracheostomy and/or PEG.
Demographic and Clinical Variables
Time frame: At enrollment (baseline).
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 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the single-center design of the study and the inclusion of sensitive psychosocial and decision-making data from patients' relatives. Although data will be analyzed in anonymized form, sharing individual-level data may pose potential risks to participant confidentiality. Aggregate results will be made publicly available through scientific publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit (ICU) Admission and Tracheostomy, run by Elazıg Fethi Sekin Sehir Hastanesi.
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 5 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) Score (time frame: Immediately before information delivery and immediately after completion of the information session (same day).). 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 27 Feb 2026.