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Nurse-Led Transfer Program With Family Involvement to Reduce ICU Patient Anxiety

Nurse-Led Transfer Programme With Patient Relatives: The Effect of Reducing Transfer Anxiety in Cardiovascular Surgery ICU Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06979414
Acronym
FICARE-TX
Enrollment
150
Registered
2025-05-19
Start date
2024-08-01
Completion date
2025-01-31
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery Recovery, Critical Care Transition, Intensive Care Unit Discharge, Postoperative Anxiety, Transfer Anxiety

Keywords

transfer anxiety, patient transfer, intensive care nursing

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.

Interventions

BEHAVIORALNurse-led Transfer Programme with Family Involvement

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.

Sponsors

Yakup Akyüz
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

No parties were masked in this study due to the nature of the intervention, which involved the visible participation of patient relatives during the ICU transfer process. The open-label design was necessary to ensure ethical and logistical feasibility.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in State Anxiety Level Using the State-Trait Anxiety Inventory (STAI-I)1. DAYThe 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.

Secondary

MeasureTime frameDescription
Change in Pulse Rate1. DAYPulse 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.
Change in Systolic Blood Pressure1. DAYSystolic 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.
Change in Respiratory Rate1. DAYRespiratory 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.
Change in Oxygen Saturation (SpO₂)1. DAYPeripheral 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.
Predictor of Anxiety Reduction1. DAYRegression analysis will be performed to evaluate the effect of caregiver presence on the change in patients' state anxiety levels.
Change in Diastolic Blood Pressure1. DAYDiastolic 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026