Transfer AnxietyFICARE-TXNCT06979414
Nurse-Led Transfer Program With Family Involvement to Reduce ICU Patient Anxiety
A study testing Nurse-led Transfer Programme with Family Involvement in people with Transfer Anxiety and Intensive Care Unit Discharge, run by Yakup Akyüz at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate whether including a patient's family member during transfer from the intensive care unit (ICU) to the general ward can help reduce anxiety in patients who have undergone cardiovascular surgery. The research is being conducted in a cardiovascular ICU in Turkey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfer Anxiety, Intensive Care Unit Discharge, Cardiac Surgery Recovery
- What is being tested?
- Nurse-led Transfer Programme with Family Involvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18 years or older
- Undergoing first-time open-heart surgery (e.g., CABG or valve replacement)
- Glasgow Coma Scale (GCS) score ≥ 14 prior to transfer
- Hemodynamically stable at the time of transfer
- Stayed in the cardiovascular surgery ICU for at least 24 hours
- Experiencing first intra-hospital transfer
- Presence of a primary caregiver available for transfer support
Who cannot join
- Emergency cardiac surgery
- Neurological or psychiatric disorders in the patient
- Postoperative complications resulting in prolonged ICU stay
- Emergency intervention required during the transfer
- Known interpersonal conflict between the patient and the caregiver
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bakircay University Cigli Training and Research Hospital, Cardiovascular Intensive Care Unit
Izmir, Türkiye, 35640
About this study
Official title: Nurse-Led Transfer Programme With Patient Relatives: The Effect of Reducing Transfer Anxiety in Cardiovascular Surgery ICU Patients
This study aims to evaluate whether including a patient's family member during transfer from the intensive care unit (ICU) to the general ward can help reduce anxiety in patients who have undergone cardiovascular surgery. The research is being conducted in a cardiovascular ICU in Turkey. Patients in the intervention group are accompanied by a close relative during the transfer process. Their anxiety levels and vital signs are measured before and after the transfer and compared to those of patients transferred without a relative.
Read the detailed description
This quasi-experimental study investigates the effect of a nurse-led transfer program involving patient relatives on transfer-related anxiety and vital signs in cardiovascular surgery ICU patients. The study is conducted in a cardiovascular intensive care unit in Turkey between August and October 2024. A total of 150 patients who undergo open-heart surgery and meet the inclusion criteria are enrolled. Participants are assigned sequentially to either the control or intervention group.
In the intervention group, a structured, nurse-led transfer protocol is applied in three phases: (1) pre-transfer preparation involving the patient's relative, (2) accompanied transfer by a relative and clinical staff, and (3) post-transfer monitoring. The control group receives routine hospital transfer procedures, which do not include family involvement.
The primary outcome is the change in patients' state anxiety, measured at three time points (before, immediately prior, and 30-60 minutes after transfer) using the State Anxiety Inventory (STAI-I). Secondary outcomes include changes in vital signs (blood pressure, pulse, respiratory rate, and oxygen saturation), recorded at the same time points.
The study is designed to contribute to the development of family-centered, nurse-led protocols aimed at improving patient comfort and emotional well-being during ICU-to-ward transfers.
- Conditions
- Transfer Anxiety, Intensive Care Unit Discharge, Cardiac Surgery Recovery, Postoperative Anxiety, Critical Care Transition
- Being tested
- Nurse-led Transfer Programme with Family Involvement
- Keywords
- transfer anxiety, patient transfer, intensive care nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Transfer Programme with Family InvolvementBehavioural
Also called Family-Inclusive Nurse-led Transfer Program
This behavioral intervention was structured in three phases: (1) Pre-transfer preparation, where the patient's primary caregiver visited the ICU for emotional support following verbal instruction and infection control measures; (2) Accompanied transfer to the general ward, led by an ICU nurse, with the caregiver present to provide emotional reassurance; (3) Post-transfer monitoring, where the patient's vital signs and anxiety levels were reassessed within 30-60 minutes of arrival. The goal of the intervention was to reduce ICU transfer-related anxiety through nurse-led, family-involved emotional support.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led Transfer With Family Involvement | Experimental | Patients in this group received a structured, nurse-led transfer program involving their primary caregiver. The intervention consisted of three phases: (1) pre-transfer emotional support through a brief ICU visit by the caregiver, (2) accompanied transfer to the general ward led by a nurse and support staff, and (3) post-transfer monitoring of anxiety and vital signs within 30-60 minutes of arrival. Receives: Behavioral: Nurse-led Transfer Programme with Family Involvement |
| Standard Transfer Without Family Involvement | No intervention | Patients in this group underwent the hospital's routine transfer process, which did not include caregiver involvement. Transfers were performed by the ICU nurse and support staff. Anxiety and vital signs were measured at the same three time points as the intervention group: before transfer, immediately prior to transfer, and 30-60 minutes post-transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Level Using the State-Trait Anxiety Inventory (STAI-I)
The State-Trait Anxiety Inventory - State Form (STAI-I) is a 20-item self-report questionnaire that measures situational anxiety levels. Each item is rated on a 4-point Likert scale. The total score ranges from 20 (lowest anxiety) to 80 (highest anxiety). Higher scores indicate a worse outcome, reflecting greater anxiety levels. The assessment will be conducted at three points: (T1) baseline, (T2) immediately pre-transfer, and (T3) 30-60 minutes post-transfer.
Measured: 1. DAY
Secondary outcomes (6)
Change in Systolic Blood Pressure
Systolic blood pressure will be measured at three time points: (T1) baseline (upon ICU discharge decision), (T2) immediately prior to transfer, and (T3) 30-60 minutes after transfer.
Measured: 1. DAY
Change in Diastolic Blood Pressure
Diastolic blood pressure will be measured at three time points: (T1) baseline (upon ICU discharge decision), (T2) immediately prior to transfer, and (T3) 30-60 minutes after transfer.
Measured: 1. DAY
Change in Pulse Rate
Pulse rate will be recorded at three time points: (T1) baseline (upon ICU discharge decision), (T2) immediately prior to transfer, and (T3) 30-60 minutes after transfer.
Measured: 1. DAY
Change in Respiratory Rate
Respiratory rate will be recorded at three time points: (T1) baseline (upon ICU discharge decision), (T2) immediately prior to transfer, and (T3) 30-60 minutes after transfer.
Measured: 1. DAY
Change in Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) will be measured at three time points: (T1) baseline (upon ICU discharge decision), (T2) immediately prior to transfer, and (T3) 30-60 minutes after transfer.
Measured: 1. DAY
Predictor of Anxiety Reduction
Regression analysis will be performed to evaluate the effect of caregiver presence on the change in patients' state anxiety levels.
Measured: 1. DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2025
- Study start1 Aug 2024
- Primary completion30 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Transfer AnxietyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a monocentric, quasi-experimental, parallel-group trial. Participants were assigned sequentially to either the control group or the intervention group based on admission order, without randomization. The intervention group received a structured nurse-led transfer program involving patient relatives, while the control group underwent standard hospital transfer procedures without family involvement. Anxiety levels and vital signs were measured at three time points across both groups for comparison.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yakup Akyüz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yakup Akyüz, Istanbul University
- Investigators
- yakup akyüz, research assistant, Principal investigator, istanbul university faculty of nursing department of surgical diseases nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979414
- Sponsor's protocol ID
- İstanbulU/2025/2
- Acronym
- FICARE-TX
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 19 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the study publication will be shared. This includes demographic data, STAI-I anxiety scores, and vital signs (blood pressure, heart rate, respiratory rate, and oxygen saturation) measured at three time points. Data will be available beginning 6 months after publication and will be accessible to qualified researchers upon reasonable request to the corresponding author. A data-sharing agreement will be required.
Publications
Ortahisar BK, Uslu Y. Intra-hospital transfer anxiety of patients in the neurosurgery intensive care unit: A prospective cohort study. Intensive Crit Care Nurs. 2023 Oct;78:103464. doi: 10.1016/j.iccn.2023.103464. Epub 2023 Jun 22.
PubMed 37354694Ghorbanzadeh K, Ebadi A, Hosseini M, Madah SSB, Khankeh H. Challenges of the patient transition process from the intensive care unit: a qualitative study. Acute Crit Care. 2021 May;36(2):133-142. doi: 10.4266/acc.2020.00626. Epub 2021 Jan 28.
PubMed 33508186Dziadzko M, Mazard T, Bonhomme M, Raffin M, Pradat P, Forcione JM, Minjard R, Aubrun F. Preoperative Anxiety in the Surgical Transfer and Waiting Area: A Cross-Sectional Mixed Method Study. J Clin Med. 2022 May 9;11(9):2668. doi: 10.3390/jcm11092668.
PubMed 35566793de Grood C, Leigh JP, Bagshaw SM, Dodek PM, Fowler RA, Forster AJ, Boyd JM, Stelfox HT. Patient, family and provider experiences with transfers from intensive care unit to hospital ward: a multicentre qualitative study. CMAJ. 2018 Jun 4;190(22):E669-E676. doi: 10.1503/cmaj.170588.
PubMed 29866892Cheng F, Yan H, Zhong J, Yang H, Nan R, Wang X, Wei Z, Dou X. Knowledge, attitude and practice of registered nurses toward ICU patients' transfer anxiety in China: A cross-sectional study. Heliyon. 2024 Apr 5;10(8):e29318. doi: 10.1016/j.heliyon.2024.e29318. eCollection 2024 Apr 30.
PubMed 38660287Chen Y, Peet J, Murray L, Ramanan M, Jacobs K, Brailsford J, Osmond A, Kajevu M, Garrett P, Tabah A, Mock C, Lin FF. Waiting to be discharged from intensive care units: Key factors shaping patient and family experiences. Intensive Crit Care Nurs. 2025 Apr;87:103961. doi: 10.1016/j.iccn.2025.103961. Epub 2025 Feb 5.
PubMed 39914326Akyuz Y, Er S, Bozok S, Uslu Y. Nurse-Led Transfer Programme With Patient Relatives: Effect on Reducing Transfer Anxiety in Intensive Care Unit Patients. Nurs Crit Care. 2025 Sep;30(5):e70153. doi: 10.1111/nicc.70153.
PubMed 40919712
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Transfer Programme With Patient Relatives: The Effect of Reducing Transfer Anxiety in Cardiovascular Surgery ICU Patients
- ClinicalTrials.gov ID
- NCT06979414
- Acronym / sponsor ID
- FICARE-TX / İstanbulU/2025/2
- Conditions
- Transfer Anxiety, Intensive Care Unit Discharge, Cardiac Surgery Recovery, Postoperative Anxiety, Critical Care Transition
- Keywords
- transfer anxiety, patient transfer, intensive care nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Yakup AkyüzUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 19 May 2025 (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.
This study aims to evaluate whether including a patient's family member during transfer from the intensive care unit (ICU) to the general ward can help reduce anxiety in patients who have undergone cardiovascular surgery. The research is being conducted in a cardiovascular ICU in Turkey. Patients in the intervention group are accompanied by a close relative during the transfer process. Their anxiety levels and vital signs are measured before and after the transfer and compared to those of patients transferred without a relative.
Detailed description
This quasi-experimental study investigates the effect of a nurse-led transfer program involving patient relatives on transfer-related anxiety and vital signs in cardiovascular surgery ICU patients. The study is conducted in a cardiovascular intensive care unit in Turkey between August and October 2024. A total of 150 patients who undergo open-heart surgery and meet the inclusion criteria are enrolled. Participants are assigned sequentially to either the control or intervention group.
In the intervention group, a structured, nurse-led transfer protocol is applied in three phases: (1) pre-transfer preparation involving the patient's relative, (2) accompanied transfer by a relative and clinical staff, and (3) post-transfer monitoring. The control group receives routine hospital transfer procedures, which do not include family involvement.
The primary outcome is the change in patients' state anxiety, measured at three time points (before, immediately prior, and 30-60 minutes after transfer) using the State Anxiety Inventory (STAI-I). Secondary outcomes include changes in vital signs (blood pressure, pulse, respiratory rate, and oxygen saturation), recorded at the same time points.
The study is designed to contribute to the development of family-centered, nurse-led protocols aimed at improving patient comfort and emotional well-being during ICU-to-ward transfers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a monocentric, quasi-experimental, parallel-group trial. Participants were assigned sequentially to either the control group or the intervention group based on admission order, without randomization. The intervention group received a structured nurse-led transfer program involving patient relatives, while the control group underwent standard hospital transfer procedures without family involvement. Anxiety levels and vital signs were measured at three time points across both groups for comparison.
| Arm | Type | Receives |
|---|---|---|
| Nurse-led Transfer With Family Involvement | Experimental | Behavioral: Nurse-led Transfer Programme with Family InvolvementPatients in this group received a structured, nurse-led transfer program involving their primary caregiver. The intervention consisted of three phases: (1) pre-transfer emotional support through a brief ICU visit by the caregiver, (2) accompanied transfer to the general ward led by a nurse and support staff, and (3) post-transfer monitoring of anxiety and vital signs within 30-60 minutes of arrival. |
| Standard Transfer Without Family Involvement | No intervention | –Patients in this group underwent the hospital's routine transfer process, which did not include caregiver involvement. Transfers were performed by the ICU nurse and support staff. Anxiety and vital signs were measured at the same three time points as the intervention group: before transfer, immediately prior to transfer, and 30-60 minutes post-transfer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Undergoing first-time open-heart surgery (e.g., CABG or valve replacement)
- Glasgow Coma Scale (GCS) score ≥ 14 prior to transfer
- Hemodynamically stable at the time of transfer
- Stayed in the cardiovascular surgery ICU for at least 24 hours
Key exclusion criteria (5 listed)
- Emergency cardiac surgery
- Neurological or psychiatric disorders in the patient
- Postoperative complications resulting in prolonged ICU stay
- Emergency intervention required during the transfer
- Known interpersonal conflict between the patient and the caregiver
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 |
|---|---|---|
| Nurse-led Transfer Programme with Family InvolvementAlso: Family-Inclusive Nurse-led Transfer ProgramThis behavioral intervention was structured in three phases: (1) Pre-transfer preparation, where the patient's primary caregiver visited the ICU for emotional support following verbal instruction and infection control measures; (2) Accompanied transfer to the general ward, led by an ICU nurse, with the caregiver present to provide emotional reassurance; (3) Post-transfer monitoring, where the patient's vital signs and anxiety levels were reassessed within 30-60 minutes of arrival. The goal of the intervention was to reduce ICU transfer-related anxiety through nurse-led, family-involved emotional support. | Behavioural | Nurse-led Transfer With Family Involvement |
Primary outcome
Change in State Anxiety Level Using the State-Trait Anxiety Inventory (STAI-I)
Time frame: 1. DAY
The State-Trait Anxiety Inventory - State Form (STAI-I) is a 20-item self-report questionnaire that measures situational anxiety levels. Each item is rated on a 4-point Likert scale. The total score ranges from 20 (lowest anxiety) to 80 (highest anxiety). Higher scores indicate a worse outcome, reflecting greater anxiety levels. The assessment will be conducted at three points: (T1) baseline, (T2) immediately pre-transfer, and (T3) 30-60 minutes post-transfer.
6 secondary outcomes
Change in Systolic Blood Pressure
Time frame: 1. DAY
Change in Diastolic Blood Pressure
Time frame: 1. DAY
Change in Pulse Rate
Time frame: 1. DAY
Change in Respiratory Rate
Time frame: 1. DAY
Change in Oxygen Saturation (SpO₂)
Time frame: 1. DAY
Predictor of Anxiety Reduction
Time frame: 1. DAY
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2025.
- Background: PubMed 37354694Ortahisar BK, Uslu Y. Intra-hospital transfer anxiety of patients in the neurosurgery intensive care unit: A prospective cohort study. Intensive Crit Care Nurs. 2023 Oct;78:103464. doi: 10.1016/j.iccn.2023.103464. Epub 2023 Jun 22.
- Background: PubMed 33508186Ghorbanzadeh K, Ebadi A, Hosseini M, Madah SSB, Khankeh H. Challenges of the patient transition process from the intensive care unit: a qualitative study. Acute Crit Care. 2021 May;36(2):133-142. doi: 10.4266/acc.2020.00626. Epub 2021 Jan 28.
- Background: PubMed 35566793Dziadzko M, Mazard T, Bonhomme M, Raffin M, Pradat P, Forcione JM, Minjard R, Aubrun F. Preoperative Anxiety in the Surgical Transfer and Waiting Area: A Cross-Sectional Mixed Method Study. J Clin Med. 2022 May 9;11(9):2668. doi: 10.3390/jcm11092668.
- Background: PubMed 29866892de Grood C, Leigh JP, Bagshaw SM, Dodek PM, Fowler RA, Forster AJ, Boyd JM, Stelfox HT. Patient, family and provider experiences with transfers from intensive care unit to hospital ward: a multicentre qualitative study. CMAJ. 2018 Jun 4;190(22):E669-E676. doi: 10.1503/cmaj.170588.
- Background: PubMed 38660287Cheng F, Yan H, Zhong J, Yang H, Nan R, Wang X, Wei Z, Dou X. Knowledge, attitude and practice of registered nurses toward ICU patients' transfer anxiety in China: A cross-sectional study. Heliyon. 2024 Apr 5;10(8):e29318. doi: 10.1016/j.heliyon.2024.e29318. eCollection 2024 Apr 30.
- Background: PubMed 39914326Chen Y, Peet J, Murray L, Ramanan M, Jacobs K, Brailsford J, Osmond A, Kajevu M, Garrett P, Tabah A, Mock C, Lin FF. Waiting to be discharged from intensive care units: Key factors shaping patient and family experiences. Intensive Crit Care Nurs. 2025 Apr;87:103961. doi: 10.1016/j.iccn.2025.103961. Epub 2025 Feb 5.
- Derived from this study: PubMed 40919712Akyuz Y, Er S, Bozok S, Uslu Y. Nurse-Led Transfer Programme With Patient Relatives: Effect on Reducing Transfer Anxiety in Intensive Care Unit Patients. Nurs Crit Care. 2025 Sep;30(5):e70153. doi: 10.1111/nicc.70153.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the study publication will be shared. This includes demographic data, STAI-I anxiety scores, and vital signs (blood pressure, heart rate, respiratory rate, and oxygen saturation) measured at three time points. Data will be available beginning 6 months after publication and will be accessible to qualified researchers upon reasonable request to the corresponding author. A data-sharing agreement will be required.
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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. This study is not recruiting at the moment.
yakup akyüz, research assistant principal investigator
istanbul university faculty of nursing department of surgical diseases nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Transfer Programme with Family Involvement in people with Transfer Anxiety and Intensive Care Unit Discharge, run by Yakup Akyüz 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 19 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 State Anxiety Level Using the State-Trait Anxiety Inventory (STAI-I) (time frame: 1. DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06979414, which also lists 7 linked publications.
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 19 May 2025.