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The COMFORT Model on Patients' Family Satisfaction in the Intensive Care Unit

The effect of the COMFORT Model on Patients' Family Satisfaction in the Intensive Care Unit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241003063250N1
Enrollment
96
Registered
2025-01-05
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with reduced level of consciousness hospitalized in intensive care unit (ICU).

Interventions

Intervention 1: Intervention group: The intervention is a daily 20-minute face-to-face communication intervention for the families of patients admitted to the ICU. Based on the daily intervention, the

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The patient's family (family member) who cooperates with the research should be fluent in Persian The patient's family member age between 18-65 The patient's family has a close relationship with the patient or has played a role in the decision-making process for the patient (spouse, father, mother, sister, brother, children, and in the absence of the above persons, other relatives of the patient). The patient's family has visited the patient at least twice during these five days. The patient's family (family member) must agree to participate in the study The age of the hospitalized patient between 18 and 65 years The patient shows a decrease in the level of consciousness and a decrease in GCS so that he is unable to communicate with the family due to a decrease in the level of consciousness (actual decrease in consciousness) or a decrease in consciousness along with medication due to being connected to a ventilator (induced decrease in consciousness). The patient is hospitalized in the special ward for more than five days (period considered for the implementation of the intervention).

Exclusion criteria

Exclusion criteria: The family member has a mental illness under the treatment of a psychiatrist. The patient has been admitted to the ward due to uncommon diseases

Design outcomes

Primary

MeasureTime frame
Patients' family satisfaction. Timepoint: 5 days after inclusion in the study. Method of measurement: Completing study questionnaires including demographic information questionnaire and family satisfaction questionnaire of patients hospitalized in the intensive care unit (24 FS-ICU).

Secondary

MeasureTime frame
Nursing care quality. Timepoint: Completion of the nursing care quality questionnaire by a clinical supervisor after observing the patient's care three times and communicating with the patient's family by each of the nurses in the ICU who have trained and provided the COMFORT model. Method of measurement: QUALPAC nursing care and quality questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Bakhshi

Yazd University of Medical Sciences

fateme.bakhshii@gmail.com+98 35 1751 3824

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026