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Completed

NCT Number: NCT06979414

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Bakircay University Cigli Training and Research Hospital, Cardiovascular Intensive Care Unit

Izmir, Türkiye, 35640, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-led Transfer Programme with Family Involvement

Behavioral

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.

Other names: Family-Inclusive Nurse-led Transfer Program

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: 1. DAY

    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.

  2. Change in Diastolic Blood Pressure

    Time frame: 1. DAY

    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.

  3. Change in Pulse Rate

    Time frame: 1. DAY

    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.

  4. Change in Respiratory Rate

    Time frame: 1. DAY

    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.

  5. Change in Oxygen Saturation (SpO₂)

    Time frame: 1. DAY

    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.

  6. Predictor of Anxiety Reduction

    Time frame: 1. DAY

    Regression analysis will be performed to evaluate the effect of caregiver presence on the change in patients' state anxiety levels.

Sponsors and collaborators

Lead sponsor

Yakup Akyüz

Other

Registry information

Official study title

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

Acronym: FICARE-TX

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 19, 2025
Registry last updated
May 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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