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

NCT06979414 | Completed

• 1 other identifier: İstanbulU/2025/2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

transfer anxiety; patient transfer; intensive care nursing

Outcome Measures

Primary Outcomes (1)

• Change in State Anxiety Level Using the State-Trait Anxiety Inventory (STAI-I)

  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.

  1. DAY

Secondary Outcomes (6)

• 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

Study Arms (2)

Nurse-led Transfer With Family Involvement

EXPERIMENTAL

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.

Behavioral: Nurse-led Transfer Programme with Family Involvement

Standard Transfer Without Family Involvement

NO INTERVENTION

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.

Interventions

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.

Also known as: Family-Inclusive Nurse-led Transfer Program

Nurse-led Transfer With Family Involvement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yakup Akyüz: lead

Study Sites (1)

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

Izmir, Türkiye, 35640, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 37354694 BACKGROUND

• 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.

  PMID: 33508186 BACKGROUND

• 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.

  PMID: 35566793 BACKGROUND

• 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.

  PMID: 29866892 BACKGROUND

• 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.

  PMID: 38660287 BACKGROUND

• 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.

  PMID: 39914326 BACKGROUND

• Akyuz Y, Er S, Bozok S, Uslu Y. Nurse-Led Transfer Programme With Patient Relatives: Effect on Reducing Transfer Anxiety in Intensive Care Unit Patients. Nurs Crit Care. 2025 Sep;30(5):e70153. doi: 10.1111/nicc.70153.

  PMID: 40919712 DERIVED

Related Links

• Related Info

Study Officials

• yakup akyüz, research assistant

  istanbul university faculty of nursing department of surgical diseases nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant, Department of Surgical Nursing

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 19, 2025
• Study Start: August 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: January 31, 2025
• Last Updated: May 19, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting documents will be available beginning 12 months after publication of the primary results and will be accessible for a period of 5 years.
• Access Criteria: Qualified researchers affiliated with academic institutions or healthcare organizations will be able to request access to de-identified individual participant data (IPD), including STAI-I scores, vital signs, and demographic information, as well as the study protocol and statistical analysis plan. Access will be granted upon submission of a data use proposal and signing of a data-sharing agreement. Requests should be submitted to the study contact via email and will be reviewed within 30 days.

Locations

TU (1)