Nurse-Led Transfer Programme With Patient Relatives: The Effect of Reducing Transfer Anxiety in Cardiovascular Surgery ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in State Anxiety Level Using the State-Trait Anxiety Inventory (STAI-I)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nurse-led Transfer With Family Involvement
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.
干预措施: Nurse-led Transfer Programme with Family Involvement (Behavioral)
Standard Transfer Without Family Involvement
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.
结局指标
主要结局
Change in State Anxiety Level Using the State-Trait Anxiety Inventory (STAI-I)
时间窗: 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.
次要结局
- Change in Systolic Blood Pressure(1. DAY)
- Change in Diastolic Blood Pressure(1. DAY)
- Change in Pulse Rate(1. DAY)
- Change in Respiratory Rate(1. DAY)
- Change in Oxygen Saturation (SpO₂)(1. DAY)
- Predictor of Anxiety Reduction(1. DAY)
研究者
Yakup Akyüz
Research Assistant, Department of Surgical Nursing
Istanbul University