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{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7795804","sourcedb":"PMC","sourceid":"7795804","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7795804","text":"2. Materials and Methods\nThis cross-sectional study was endorsed by the Local Health Authority (LHA) of the Province of Reggio Emilia (Italy), with a population of 533,158; 66% of the population is between the ages of 18 and 70. This province was one of the most affected by the first epidemic peak of COVID-19 in Italy, with a daily incidence rate of about 8/1000 inhabitants during lockdown (10 March–18 May 2020) [7].\nAn online survey investigating lifestyle habits and any changes that occurred during lockdown was developed by two epidemiologists, two physiotherapists, and one occupational therapist. The survey did not collect personal data and was completely anonymous as to the source, which is why the consulted Local Ethics Committee deemed approval unnecessary. However, the survey underwent an ethics review conducted by an expert in the field; after approval, it was disseminated online to individuals living in the Province of Reggio Emilia. The survey was advertised through the websites and social media of the LHA, the major municipalities of the province, the network of the municipal pharmacies, and the local patient associations that joined the initiative. Citizens could access the survey without restrictions and in complete anonymity from 4 May 2020 until 15 June 2020.\nThe survey (Supplementary Material File S1) explored the following areas: (a) sociodemographic data (14 questions); (b) work-related data (5 questions); (c) use of digital devices (3 questions); (d) lifestyle and general health (23 questions); (e) use of local social support services (3 questions); and (f) symptoms of psychological distress, i.e., the sense of tension, upset, worry, fear, loneliness, and/ or uncertainty (one question).\nApart from two open-ended questions, the answers were multiple-choice. In some cases, more than one choice was possible. The survey took an average of 15 min to complete.\nThe main outcome of this cross-sectional study was to describe the quality of sleep during and immediately after lockdown, investigated through the following two questions: “Have your sleep habits changed since the beginning of lockdown (amount and/or regularity of sleep)?” and “How do you rate your sleep quality now”?\nWe also searched for associations between sleep quality categories and sociodemographic and occupational characteristics, changes in lifestyle (physical activity, eating habits, smoking, and alcohol consumption), and psychological distress.\n\n2.1. Data Privacy and Consent for Participation\nDuring the informed consent process, participants were informed that all data would be anonymized at the source and would be used exclusively for research purposes. By completing the survey, participants voluntarily consented to participate in this study. As response would be saved only by clicking the “submit” button, that participant could stop participating in the study at any stage before submission, and their responses would not be saved. As the survey was disseminated to the local community, participants were not asked to provide name, date of birth, residency, and/or job to ensure complete anonymity.\n\n2.2. Statistical Analysis\nParticipants who completed the survey were categorized based on the dependent variable, i.e., their self-reported quality of sleep. They were grouped by sex, age class, education level, household composition, any financial problems, occupational status, lifestyle habits, and psychological distress. We report both the number and proportion of missing values. We looked for associations (crude odds ratio—OR—and its 95% confidence interval—95% CI) between the sociodemographic and occupational characteristics, changes in lifestyle, and the presence of psychological distress as independent variables and the quality of sleep categories. Separate models of multivariate regression analysis, all adjusted for age, sex, and education level, were built for any of the independent variables which, based on the crude OR and its 95% CI, proved to be strongly associated with quality of sleep. Missing values were not included in the analyses. Statistical analyses were performed using jamovi 1.2.27 (Jamovi Project, Sydney, Australia) 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