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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05197491
Other study ID # R 179
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 1, 2023

Study information

Verified date April 2023
Source Fayoum University
Contact rehab A aboshama, Ass Professor
Phone 01156608221
Email ras07@fayoum.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The COVID-19 crisis has rapidly become the most significant public health crisis of our times. It has particularly impacted healthcare workers (HCW) due to the over-whelming of healthcare resources, as well as a critical absence of protective equipment and risk to their own health as well as the risk of exposure to their family. All these factors have likely resulted in significant levels of stress, anxiety, and affection of the general health


Description:

During the first wave of the pandemic, overstretched healthcare systems left health workers in hard-hit countries struggling with long working hours, fatigue, and extreme psychological stress. Rapidly vanishing supplies, national lockdown, and a feeding frenzy on the open market for personal protective equipment (PPE) led to shortages. Healthcare workers often had to care for patients with suspected or confirmed COVID-19 infection without proper training or adequate PPE. This contributed to an increased risk to healthcare workers during the initial phase of the pandemic. Study Methods: This is a retrospective cross-sectional study that will be conducted among healthcare professionals working in the obstetrics and gynecology department, Fayoum University Fayoum, Egypt. A survey-based study will be conducted between January 15 and March 1, 2022, using the database of Fayoum University. A self-administered online survey consisting of 80 questions was developed.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2023
Est. primary completion date August 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - All obstetrics and gynecology department healthcare workers who were or had been resident, physicians or consultant physicians, nurses, and paramedical healthcare active during the COVID-19 pandemic period at a designated Fayoum university hospital, regardless of gender, age, experience, and duration of employment. Exclusion Criteria: - Exclusion criteria: 1. physicians who were retired or did not currently work in a designated COVID-19 hospital. 2. Physicians from other specialties 3. Physicians were on leave during the pandemic for various reasons.

Study Design


Locations

Country Name City State
Egypt Fayoum university Fayoum

Sponsors (1)

Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of irregular menstrual cycle Irregular menstrual cycle 6 month after working in the pandemic
Primary Length of cycle Length of cycle (days) 6 month after working in the pandemic
Primary Rate of prolonged bleeding per cycle Duration of bleeding (day) 6 month after working in the pandemic
Primary Amount of flow Number of used tampons (pads) during bleeding 6 month after working in the pandemic
Primary Rate of dysmenorrhea Dysmenorrhea status 6 month after working in the pandemic
Primary Recognizing the stress related to work in the Covid-19 pandemic The person is asked to answer the questions on the scale over the symptoms she has experienced during the past year including today'. Each item scores between 0 and 3 as none, mild, moderate, and severe, respectively. 6 month after working in the pandemic
Primary Recognizing a change in sexual life The participants will answer the survey by yes or no. 6 month after working in the pandemic
Secondary The number of differences in menstrual cycle length Menstrual cycle difference between Covid-19 positive and negative healthcare workers (days) 6 month after working in the pandemic
Secondary The number of differences in bleeding days Duration of bleeding difference between covid positive and negative healthcare workers (days) 6 month after working in the pandemic
Secondary The number of differences in the amount of flow Amount of flow difference between covid positive and negative healthcare workers (tampons) 6 month after working in the pandemic
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