Humanistic care in the ICU: effects on patient dignity, delirium and family satisfaction - a non-randomised clinical trial protocol.

INTRODUCTION

Critical care patients face varying degrees of physical and psychological stress; in recent decades, the increasing focus on technologies and clinical processes has led to dehumanisation. In contrast, humanistic care has been introduced as an essential care paradigm, emphasising comprehensive care and considering all stakeholders in the care process (patient, family and staff). In addition to improving clinical outcomes, this approach focuses on family satisfaction, preserving the human dignity of patients and reducing the incidence of acute cognitive disorders such as delirium; therefore, the aim of this study is to assess the impact of humanistic care on these three key areas in the intensive care unit (ICU).

METHODS AND ANALYSIS: This non-randomised clinical trial was performed in the ICU. There are two distinct groups (194 patients)-a control group that receives usual care and an intervention group that receives both usual care and a set of targeted interventions based on the seven components of the Humanising Intensive Care (HU-CI) model ('open-door ICU', 'communication', 'patient well-being', 'caring for professionals', 'post-ICU syndrome', 'end-of-life care' and 'humanised infrastructure') for three main groups including healthcare personnel, patients and their families. The primary outcome is delirium (Confusion Assessment Method for the Intensive Care Unit tool), and secondary outcomes are family satisfaction (Family Satisfaction in the Intensive Care Units Questionnaire) and human dignity (Patient Dignity Inventory). Finally, the data will be analysed through STATA V.18 software using the statistical methods of independent t-test or its non-parametrical equivalent, χ2 or Fisher's exact tests, Mann-Whitney or Kruskal-Wallis tests, multivariate binary logistic regression models or analysis of covariance, and non-linear mixed models.

ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Committee of the Tehran University of Medical Sciences (Ethical code: IR.TUMS.FNM.REC.1404.086). Informed consent will be obtained from all participants. The data will be shared on reasonable request to the corresponding author.

TRIAL REGISTRATION NUMBER: IRCT registration number: IRCT20250727066651N1. Registration date: 30 July 2025.