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Development and psychometric evaluation of a safety instrument for patients with cognitive impairment in hospital: an exploratory sequential mixed-methods study protocol in Iran

Por: Shahmari · M. · Palese · A. · Bahramnezhad · F. · Shafiee Sabet · M. · Dehghan Nayeri · N.
Introduction

Cognitive impairments, such as dementia and Alzheimer’s disease, are considered a significant public health challenge as they affect mental functions like memory, attention, language and decision-making. With the growing number of older individuals, the prevalence of these diseases is also increasing and is projected to reach 152 million worldwide by 2050. These disorders result in difficulties with judgement, communication and daily activities, leading to more hospitalisations and risks such as disorientation in the environment and a higher likelihood of falls. Current hospital safety assessment tools mainly focus on physical aspects and overlook other crucial factors. Therefore, this study aims to clarify the concept of safety challenges for patients with cognitive impairment and to develop and psychometrically validate a multidimensional instrument for use in hospital settings.

Methods

A sequential exploratory study with mixed methods will be conducted. In the first qualitative phase, based on a content analysis approach, the aim is to explain and clarify safety issues in patients with cognitive impairment. Participants will be purposively selected until saturation is reached in educational-therapeutic centres affiliated with the University of Medical Sciences, and unstructured in-depth interviews will be conducted. The data will be analysed simultaneously using MAXQDA V.20 software. Additionally, a literature review on safety issues in patients with cognitive impairment will be conducted to supplement aspects that may not have emerged in the interviews.

In the second phase, an instrument based on the inductive–deductive method will be developed. The items will be created based on the participants’ experiences and the literature review. Face, content and construct validity, as well as reliability, will be assessed. Data synthesis will involve a linkage strategy, where the qualitative data will be linked to the quantitative data immediately after the completion of the qualitative phase, once the protocols are developed.

Ethics and dissemination

This study is part of a postdoctoral project approved by the Tehran University of Medical Sciences Research Ethics Board (IR.TUMS.FNM.REC.1403.006). Findings will be disseminated at the local, national and international levels.

Effectiveness of nutritional intervention provided to older people and nutrients indicating food insecurity in primary care settings in Tehran: protocol of a prospective population-based cohort study

Por: Asghari Hanjani · N. · Olyaeemanesh · A. · Shafiee · G. · Zabihi · M. · Azadbakht · L.
Background and aim

With the growing older population, ensuring effective, accessible nutritional support within primary care as a first line of medical care is becoming increasingly important. Nutritional counselling is a promising approach to enhancing health outcomes and independence among older adults. However, a stronger evidence base is needed to assess its true effect and inform clinical decisions. Additionally, food insecurity remains an under-recognised issue in this population and is often overlooked in primary care settings. This highlights the need for simple, practical methods to identify those at risk. This study aimed to assess the effectiveness of nutritional intervention provided to older people and determine which nutrients may indicate food insecurity in primary care settings in Tehran.

Methods

The study will be conducted in two phases. The first phase is a prospective cohort study (single cohort). The second phase is a cross-sectional study on older people who refer to primary care settings affiliated with the Tehran University of Medical Sciences. In the first phase, the effectiveness of nutritional interventions – including counselling and diet – is evaluated based on anthropometric indicators (weight, waist circumference, calf circumference, arm circumference and waist-to-height ratio), blood pressure and scores from the Mini Nutritional Assessment, health-related quality of life, dietary intake and physical activity. Assessments will be evaluated prospectively at the beginning of the study, after 3 months, and at the end of the study. In the second phase of the cross-sectional study, by examining dietary intake and food insecurity, we will identify the specific nutrient or food group that serves as an indicator of food insecurity in the diet of older individuals. Intakes below 50% and 75% of the recommended daily allowance will be analysed. Through sensitivity and specificity analysis, we will identify which nutrient or food group is strongly associated with food insecurity in older people.

Ethics and dissemination

This study received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1402.474). Study findings will be disseminated through peer-reviewed journal articles, presentations at national and international conferences and meetings with the Iranian Ministry of Health, facility and community stakeholders.

Registration number

69772

Psychological birth trauma and its related factors, and providing strategies for prevention of psychological birth trauma: protocol for an explanatory sequential mixed-method study

Background

Childbirth can have psychological, social and emotional effects on women and their families. Psychological birth trauma (PBT) is defined as the emotional distress and mental health challenges resulting from negative or distressing experiences during the childbirth process. Labour management plays an important role in the health of women and children. Consequently, the study aims to assess the status of PBT among Iranian women, identify factors influencing it and suggest effective preventive strategies.

Methods and analysis

This study is a mixed-method research with an explanatory sequential approach. The first phase is quantitative and cross-sectional, involving 300 postpartum women visiting health centres in Tabriz-Iran. In this phase, cluster sampling will be used, and data will be collected using the following questionnaires: Sociodemographic and Obstetric Characteristics, Birth Trauma Scale, PTSD Symptom Scale 1, Perceived Quality of Care Scale, Childbirth Experience Questionnaire version 2.0, Edinburgh Postpartum Depression Scale, Postpartum Specific Anxiety Scale Research Short-Form and the questionnaire on the desire for subsequent pregnancy. The second phase is qualitative, and participants will be selected based on the results of the quantitative phase and extreme cases, using purposive sampling. Data analysis will be performed using qualitative content analysis with a conventional approach. Qualitative data will be collected through in-depth and semi-structured individual interviews with open-ended questions. In the third phase, strategies to prevent childbirth psychological trauma will be designed by integrating the results of the quantitative and qualitative studies, reviewing the literature and gathering expert opinions using a modified Delphi study. Examining PBT and its influencing factors can provide culturally relevant, evidence-based strategies. These strategies can be effective in improving the quality of care for women during childbirth.

Ethics and dissemination

This study has received approval from the Ethics Committee of Tabriz University of Medical Sciences in Tabriz, Iran (code number: IR.TBZMED.REC.1402.945). All participants will provide written informed consent before taking part in the study. The outcomes will be shared through articles published in journals, presentations at medical conferences, the validation of a reliable scale for assessing the level of PBT in postpartum women, and the provision of strategies to prevent childbirth psychological trauma. These resources will be valuable for policymakers and healthcare providers.

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