Authors: Parvaneh Asgari, Samrand Fattah Ghazi, Fatemeh Mansoor Samaei
Categories: Intensive Care, Delirium, Clinical Trial, Intensive Care Units, Family, Protocols & guidelines
Source: BMJ Open
Authors: Parvaneh Asgari, Samrand Fattah Ghazi, Fatemeh Mansoor Samaei
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).
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, χ^2^ 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.
The study protocol has been approved by the Ethics Committee of the Tehran University of Medical Sciences (Ethical 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.
IRCT registration IRCT20250727066651N1. Registration 30 July 2025.
The intensive care unit (ICU) is a hospital unit with specialised equipment and skilled personnel for the immediate and continuous care of critically ill patients.^1^ ICU patients are faced with different degrees of physical and psychological stress due to their complex conditions and the physical environment of the unit.^2^ In recent decades, the increasing reliance on advanced medical technologies and the prioritisation of clinical processes have diminished attention to the human dimensions of care;35 consequently, patients’ emotional needs and personal identities have been overlooked, leading to considerable distress and concern among patients and their families;^6^ in other words, dehumanisation has happened.^7^ The care process has evolved over time from patient-centred care to person-focused care and finally to humanistic care.^5^ In humanistic care—the final stage of care—a holistic perspective is adopted, ensuring respect for patient’s values, needs and preferences while actively involving them in decision-making.811 This approach also recognises all stakeholders, including patients, family caregivers and healthcare providers, and emphasises their interactions with the care process.1214
The HU-CI model, developed in Spain around 2014, and formally introduced in 2019, is a comprehensive framework designed to enhance and validate humanistic care quality in ICU settings. It has seven stages, including ‘open-door ICU’, ‘effective communication’, ‘patient well-being’, ‘caring for professionals’, ‘post-intensive care unit syndrome (PICS)’, ‘end-of-life care’ and ‘humanised infrastructure’. Additionally, this model focuses on the patient, family caregiver and treatment team as an integrated whole.^15^
Delirium is an ignored symptom of organ dysfunction in the ICU. This condition is common in ICU patients and increases mortality, length of hospitalisation, treatment costs and the burden on families and caregivers.^16 17^ In ICU patients, flexible visitation reduces delirium and the severity of anxiety symptoms and increases patient and family satisfaction; according to studies, the duration of visits, while adhering to infection control indexes, does not increase the risk of acquired infections.1821 Delirium management has advanced in recent decades, and now it is time to improve care, specifically humanistic delirium care.^22^ Family presence and satisfaction are central to delivering humanistic care and improving ICU quality.^23^ Family members of ICU patients often experience significant psychological distress, including post-traumatic stress disorder, anxiety and depression.^6^ Addressing the emotional and informational needs of family members is essential, as it enhances their well-being and leads to higher overall satisfaction with patient care.^23^ The humanistic care approach improves the environment and the quality of care by integrating human and scientific values and respecting human dignity.^24^ Dignity is a central and complex phenomenon that is created through the caring relationship and defines the direction of professional nursing care.^25^
Most research studies are qualitative, and quantitative studies address only limited aspects of the model within specific healthcare contexts.1618 24 2628 Considering the evolving care paradigm and the lack of comprehensive model-based research, this study aims to evaluate the effect of humanistic care on family satisfaction, delirium and human dignity of patients hospitalised in the ICU.
Patients admitted to the general ICU ward of Mahdi Clinic at Imam Khomeini Hospital Complex and their families who meet the inclusion criteria for this study.
The present study is a quasi-experimental study, the non-randomised clinical trial type, with a post-test-only design and two groups (control and experimental). The protocol structure is written based on the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 checklist. This trial was prospectively registered at the Iranian Registry of Clinical Trials on 30 July 2025, prior to enrolment of the first participant.
This study is single-centre and will be conducted in the general ICU of Mahdi Clinic at Imam Khomeini Hospital Complex, affiliated with the Tehran University of Medical Sciences, in Iran.
Inclusion and exclusion criteria for all three groups of patients, healthcare personnel and family caregivers are listed in table 1.
To prevent data contamination in sampling, the control group is examined first, followed by the intervention group. The control group receives routine care, and the visiting time is once a day for 30 min.
This study will be conducted interdisciplinary with the coordination and presence of ICU nurses, physicians and nurse assistants. According to studies, delirium is also part of PICS, and preventive measures for it mainly include delirium prevention and management, family involvement and presence, and environmental management;2931 therefore, measures related to these items have also been planned in the present study to prevent PICS. In the intervention group, in addition to routine care, a set of targeted interventions will be implemented based on the seven components of the HU-CI model for three main groups, including ‘healthcare Personnel’, ‘patients’ and ‘family caregivers’.
The HELLO Bundle (H: humanise / E: empathy / L: listen / L: learn / O: open) will be used for healthcare personnel (ICU head nurse, physician, nurses and nurse assistants) as one of the key measures in implementing the humanistic care model. The purpose of implementing this protocol is to boost team spirit, create a more friendly and intimate atmosphere throughout the day, and constantly remind personnel of the importance of human interaction and positive communication. This intervention will last 4 weeks and includes the
A brochure titled ‘Welcome Guide’ will be provided to the families of ICU patients, which will include information about the ICU, visiting time, expectations from families and other important points related to their patient’s treatment and care process.^15^ The ICU physician in charge will also explain the patient’s condition and treatment process to the family caregiver. The visiting time will be increased compared with the control group, and it will be twice a day, with a maximum of 30 min per visit.^18^
Before any intervention, healthcare personnel will introduce themselves to the patient and provide necessary explanations about the procedures. Equipment, including hearing aids, glasses, dentures, eye patches and earplugs, will be provided to patients if they desire or require them.^32^ A number of clocks and dates are placed within the patients’ line of sight. Appropriate measures will be taken to reduce excess light and noise in the environment, such as turning off the lights above patients’ beds at night, optimising the volume of device alarms, and using similar methods.
A summary of these interventions based on the HU-CI model is classified in table 2.
The primary outcome is delirium in patients. It will be assessed two times per day by the researcher using the Confusion Assessment Method for the Intensive Care Unit.^33 34^ This tool was designed by Inouye and colleagues^35^ in 1990 to assess, diagnose and monitor the delirium in ICU. In Iran, it was validated and made reliable by Zolfaghari and colleagues (2012). There is equivalent reliability between raters with a correlation coefficient of 0.94, and in terms of validity, its specificity is 99.1% and its sensitivity is 66.7%.3638 This tool has four stages, including sudden and fluctuating changes in consciousness, inattention, altered level of consciousness, and disorganised thinking. Generally, in the above four-stage test, a positive score in both of stages one and two and either of stages three or four is considered delirium.^36^
The secondary outcomes are the satisfaction of the patients’ families and the patients’ sense of human dignity, which will be assessed with the Family Satisfaction in the Intensive Care Units (FS-ICU-24) Questionnaire and Patient Dignity Inventory (PDI), respectively, after the patient’s discharge from the ICU and transfer to the ward.
The FS-ICU-24 Questionnaire was designed by Heyland and Tranmer in 2001 to assess the satisfaction of families of ICU patients. The shortened version of this questionnaire (The FS-ICU-24)^39^ was validated and made reliable by Hayatinia and colleagues (2021) in Iran. Cronbach’s α coefficients for the dimensions and the entire questionnaire are 0.758 and 0.789. This questionnaire has 24 questions on a five-point Likert Scale; its total score ranges from 0 to 100, and a higher score indicates greater satisfaction.4042
The PDI was designed by Chochinov and colleagues in 2008 to assess patient dignity^43^ and was validated and made reliable by Adeleh Mashayekhi and colleagues (2014) in Iran. Its validity was confirmed, and reliability was determined by calculating the internal correlation coefficient, which was 0.78 for Cronbach’s α. This questionnaire has 25 questions with a five-point Likert Scale; its total score ranges from 25 to 125, and the lower scores are associated with a greater sense of dignity.^44^
The schedule of enrolment, interventions and assessments is summarised in table 3, based on the SPIRIT figure. The control group was collected first, then the intervention group after 6 weeks (1 month of HELLO intervention + 2 weeks for washout).^45^ The duration of this study is planned to be 18 weeks from 23 May 2026 to 25 September 2026 (6 weeks control group + 4 weeks HELLO Bundle intervention + 2 weeks for washout + 6 weeks intervention group).
To determine the sample size, studies comparing the difference in proportions between two groups were used. According to the data presented in the study by Malik and colleagues,^46^ the incidence of delirium in the group treated with the humanistic protocol was 36% while it was 56% in the control group. Based on the following formula, considering α=0.05 and 80% power, the required sample size per group was calculated to be 97 patients.
Randomisation: Not applicable.
Blinding: Not applicable.
STATA V.18 will be employed to review and analyse all collected data within the research project. Quantitative results will be expressed as means and SD, while qualitative results will be summarised using frequency counts and percentages. In order to evaluate the normality of the sample distribution, the Kolmogorov-Smirnov test will be performed. Based on whether the sample distribution is normal or not, independent t-tests or their non-parametrical equivalent will be used to evaluate mean differences between the groups. To compare nominal qualitative variables, χ^2^ tests or Fisher’s exact tests will be performed. (To compare ordinal qualitative variables, Mann-Whitney U tests or Kruskal-Wallis tests will be performed.) If the distributions of prognostic factors between the two groups were different, we will use multivariate logistic regression analyses to modify the qualitative bivariate outcomes (or an ANCOVA model (analysis of covariance) to modify quantitative variables outcomes). If the independent variables in the model are random and constant, non-linear mixed models will be used for statistical analyses. In all analyses, a value of p<0.05 will be considered as the significance level.
This study determines the effect of humanistic care based on the HU-CI model on ICU patients. This model has seven dimensions, including ‘open-door ICU’, ‘effective communication’, ‘patient well-being’, ‘caring for professionals’, ‘post-intensive care unit syndrome (PICS)’, ‘end-of-life care’ and ‘humanised infrastructure’.^15^
Based on past evidence, care was, in order, patient-centred and person-focused, and currently the care paradigm has shifted and evolved comprehensively into humanistic care.^5^ Today, there is evidence that flexible visiting in the ICU, with adherence to standard infection control protocols, reduces delirium and the severity of anxiety symptoms, and increases patient and family satisfaction.1821 A recent intervention in the cardiac surgery ICU using a humanistic care approach improved cardiopulmonary function and reduced anxiety and depression while enhancing patients’ self-efficacy, sleep quality and quality of life (p<0.05).^27^ Humanistic care review studies extracted humanistic approaches^24^ or demonstrated the effectiveness of this care approach.^28 47^
The majority of the types of the reviewed studies were reviews or qualitative, with their primary aim being to identify concepts, components and experiences related to humanistic care. Despite the theoretical richness of these studies, empirical and interventional evidence regarding the impact of this model on patient and family outcomes is very limited and insufficient. Quantitative studies have also only examined a portion of the dimensions of this model in the context of other societies with their own specific healthcare system conditions.1618 24 2628
The study design, based on the latest humanistic care model, considering all stakeholders in the treatment process (patient, family caregiver and healthcare personnel), and the implementation of an interdisciplinary intervention with the coordination and presence of ICU nurses, physicians and nurse assistants, are strengths of the current study. Given that the current research is an interdisciplinary educational programme led by a nurse, the communication loop between the patient, family caregiver, physician, nurse and other members of the treatment team is strengthened, which in turn improves patients’ health status and family satisfaction. An adequate sample size (two groups of 194 people) and the use of internationally validated tools will increase the accuracy of evaluating the intervention’s effects. Given the current state of ICU care in hospitals in developing countries, implementing this protocol can serve as a new pattern for expanding interdisciplinary and humanistic care, considering all care stakeholders.
In addition, this study’s results can guide the development of educational programmes for the treatment team and the review of hospital management and cultural policies with a humanistic approach. Implementing these interventions can shift the care paradigm to humanistic care and improve the quality of care by taking a holistic view of the patient, family caregiver and healthcare personnel.
The study will conform to the principles of the Declaration of Helsinki. This study was approved by The Ethics Committee of the Tehran University of Medical Sciences. (Ethical IR.TUMS.FNM.REC.1404.086). Informed written consent will be provided by all study subjects. They also have the right to withdraw from the study whenever desired, and their information will be kept confidential. Also, the study will follow the SPIRIT guidelines.^48^