Clinical trial NCT06979414: Nurse-Led Transfer Program With Family Involvement to Reduce ICU Patient Anxiety
Official title: Nurse-Led Transfer Programme With Patient Relatives: The Effect of Reducing Transfer Anxiety in Cardiovascular Surgery ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfer Anxiety
Intensive Care Unit Discharge
Cardiac Surgery Recovery
Postoperative Anxiety
Critical Care Transition
Keywords: transfer anxiety
patient transfer
intensive care nursing
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2025-05-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in State Anxiety Level Using the State-Trait Anxiety Inventory (STAI-I)
timeFrame: 1. DAY
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: 1. DAY
measure: Change in Diastolic Blood Pressure
timeFrame: 1. DAY
measure: Change in Pulse Rate
timeFrame: 1. DAY
measure: Change in Respiratory Rate
timeFrame: 1. DAY
measure: Change in Oxygen Saturation (SpO₂)
timeFrame: 1. DAY
measure: Predictor of Anxiety Reduction
timeFrame: 1. DAY
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bakircay University Cigli Training and Research Hospital, Cardiovascular Intensive Care Unit
state: Türkiye
Study officials:
affiliation: istanbul university faculty of nursing department of surgical diseases nursing
name: yakup akyüz, research assistant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ghorbanzadeh 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.
citation: Dziadzko 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.
citation: de 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.
citation: Cheng 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.
citation: Chen 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.