ABSTRACT
The COVID-19 pandemic has evolved into a severe psychosocial crisis affecting patients, their relatives, friends, and healthcare professionals. In Italy, public health residents (PHRs) remain essential to the national response to the pandemic. To assess their mental sphere, the "Public Mental Health" working group of the medical residents' Assembly of the Italian Society of Hygiene and Preventive Medicine has designed the Public Health Residents' Anonymous Survey in Italy (PHRASI). This is a nation-wide cross-sectional study based on an 88-item self-administered voluntary survey that evaluates how sociodemographic variables are associated with mental issues, including wellness, eating disorders, sleeplessness, alcohol misuse, depression, and anxiety. Data will be gathered by disseminating a Google Forms link across the Assembly network of medical residents. All PHRs enrolled in a four-year program in one of the Italian postgraduate schools of public health will be qualified as participants. PHRASI aims to draw a comprehensive and detailed picture of the mental health state of Italian PHRs. PHRs are a significant group of healthcare professionals that may serve as a future benchmark for developing and enacting regulations intended to support the mental health of healthcare professionals.
Subject(s)
COVID-19 , Public Health , Humans , Mental Health , Cross-Sectional Studies , Pandemics , Surveys and Questionnaires , Italy/epidemiologyABSTRACT
BACKGROUND: Psychological interventions may reduce fertility problems. Positive emotion, engagement, meaning, positive relationship and accomplishment (PERMA) is a cognitive intervention and integrative-behavioral couple therapy (IBCT) is a behavioral intervention. Appropriate mental interventions are important in infertility treatment. OBJECTIVE: To investigate the effect of the PERMA model vs. IBCT in reducing the fertility problems of couples. MATERIALS AND METHODS: The content of the interventions was developed and adjusted based on a literature review and the opinions of experts. In this three-arm parallel randomized clinical trial, 42 couples undergoing infertility treatment will be allocated randomly into three groups (n = 14 couples/each). Group 1 will receive the PERMA intervention, group 2 will receive the IBCT intervention, and group 3 as the control group will receive an infertility treatment training program intervention. The primary outcome will be the fertility problems, which will be measured by completing a fertility problem inventory at baseline, as well as in the 5 th and 9 th wk as a follow-up. Another primary outcome, satisfaction with the intervention, will also be assessed in the 5 th and 9 th wk. The secondry outcome will be a positive pregnancy test at wk 12. The interventions will be conducted through a combination of face-to-face and online via WhatsApp. CONCLUSION: This study will assess social, sexual, and parenthood concerns. A combination of online and face-to-face interventions will be appropriate given the COVID-19 pandemic. Couple's counseling may provide better counseling outcomes for fertility problems in comparison with group counseling. This study will try to optimize resilience during infertility treatment through learning better relationship and problem-solving skills, and may have an indirect impact on pregnancy rate, burden of infertility, and costs of treatment due to increased effectiveness.
ABSTRACT
OBJECTIVES: This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19). TRIAL DESIGN: This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial. PARTICIPANTS: Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran. INTERVENTION AND COMPARATOR: Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. MAIN OUTCOMES: The main outcomes are changes in the coronavirus disease's clinical symptoms including duration and severity from baseline to the end of 2 weeks. RANDOMIZATION: Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial's pharmacist with the use of random-number tables. BLINDING (MASKING): The trial-group assignment will be concealed from all participants, clinicians, and investigators throughout the trial. To ensure blinding, randomization sequences will be kept in identical, opaque, sealed, sequentially numbered envelopes. Only the trial's pharmacist has access to the randomization list. Also, the placebo tablet will be similar to the propolis tablet in terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labelling, and packaging. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The calculated total sample size is 80 patients, with 40 patients in each group. TRIAL STATUS: The protocol is Version 1.0, October 10, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by March 21, 2021. TRIAL REGISTRATION: The name of the trial register: The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial. IRCT registration number: IRCT20200802048267N1 . Date of trial registration: 20 October 2020, retrospectively registered. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.