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

NCT ID: NCT06979414

Last Updated: 2025-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Nurse-led Transfer Programme with Family Involvement

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nurse-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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Family-Inclusive Nurse-led Transfer Program

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yakup Akyüz

OTHER

Sponsor Role lead

Responsible Party

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Yakup Akyüz

Research Assistant, Department of Surgical Nursing

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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yakup akyüz, research assistant

Role: PRINCIPAL_INVESTIGATOR

istanbul university faculty of nursing department of surgical diseases nursing

Locations

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

Izmir, Türkiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 37354694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33508186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35566793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29866892 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38660287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39914326 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40919712 (View on PubMed)

Related Links

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Other Identifiers

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İstanbulU/2025/2

Identifier Type: -

Identifier Source: org_study_id

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