Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)
Starting soon · Not applicable
Conditions studied: Caregiver, ICU Patients
In brief
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.
Key facts
- Study ID
- NCT07603219
- Run by
- Medical University of Gdansk
- People needed
- 20
- Starts
- 2026-09-01
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients:
- Age >18 years
- ICU stay > 24h
- Caregivers:
- Age >18 years
- consent to participate in the study
- meeting the definition of a caregiver
- able to complete questionnaires
You may not qualify if…
- Patients:
- Age < 18 years
- Discharged/Deceased form ICU < 24h
- Caregivers:
- Age < 18 years
- without cognitive impairment
- no consent to participate in the study
- No able to complete questionnaires
Full record on ClinicalTrials.gov
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