Nurse-Led Transfer Program With Family Involvement to Reduce ICU Patient Anxiety (FICARE-TX)

Yakup Akyüz

Status: Completed

Conditions: Intensive Care Unit Discharge; Postoperative Anxiety; Transfer Anxiety; Critical Care Transition; Cardiac Surgery Recovery

Treatments: Behavioral: Nurse-led Transfer Programme with Family Involvement

Study type: Interventional

Funder types: Other

Identifiers

NCT06979414

İstanbulU/2025/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Nurse-led Transfer With Family Involvement

Experimental group

Description:

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.

Treatment:

Behavioral: Nurse-led Transfer Programme with Family Involvement

Standard Transfer Without Family Involvement

No Intervention group

Description:

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.