Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)

NCT07603219 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-22

No results posted yet for this study

Summary

Admission of a loved one to the intensive care unit (ICU) is a highly stressful experience for family members and caregivers. Many caregivers report increased levels of anxiety, stress, and depressive symptoms, often due to uncertainty about the patient's condition and difficulties in understanding medical information. Improving communication and providing clear, structured information may help reduce this psychological burden.

This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a nurse-led educational intervention called "Nurses for Family" (N4F), designed to support caregivers of ICU patients.

The study will include adult caregivers (aged 18 years or older) of patients admitted to the ICU for more than 24 hours. Participants must provide informed consent and be able to complete questionnaires independently. A total of 20 participants will be enrolled and allocated to one of two groups: an intervention group (receiving nurse-led educational support) or a control group (receiving standard care).

Data will be collected at two time points during the ICU stay. At baseline (24-48 hours after ICU admission), participants will complete the Hospital Anxiety and Depression Scale (HADS), which measures symptoms of anxiety and depression. At follow-up (7 days later), participants will complete the HADS again, along with the Family Satisfaction in the ICU (FSICU-24) questionnaire. Feasibility will be assessed based on recruitment and retention rates, adherence to the study protocol, and completeness of data collection. Acceptability will be evaluated through interviews conducted with participants from the control group.

This pilot study is expected to determine whether the N4F intervention is feasible and acceptable in a clinical setting and to provide preliminary evidence regarding its potential to reduce psychological distress and improve satisfaction among caregivers of ICU patients.

Conditions

  • Caregiver
  • ICU Patients

Interventions

OTHER

Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)

The intervention was designed as a two-stage process: a theoretical component and a practical component: (I) The intervention begins by providing families with an informational brochure titled "Guide to the Intensive Care Unit." This initial step aims to reduce uncertainty and anxiety by setting clear expectations regarding the stay in the ICU. The theoretical part will be delivered by an experienced ICU nurse, a specialist in intensive care, in person in a designated room to ensure a comfortable environment for the family. (II) After distributing the brochure, the ICU nurse conducts an educational session at the patient's bedside. During this session, families receive explanations about the equipment in the intensive care unit, monitoring devices, and the patient care process. The final component of the intervention is a support brochure for families titled "How You Can Help a Loved One".This brochure contains practical guidance on supporting the patient.

Sponsors & Collaborators

  • Université de Montréal

    collaborator OTHER
  • Medical University of Gdansk

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-05-31
Completion
2027-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603219 on ClinicalTrials.gov