NCT05197491

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

January 7, 2022

Last Update Submit

April 27, 2023

Conditions

Keywords

COVID-19Work-related stressHealth care workerSurveyMenstrual irregularity

Outcome Measures

Primary Outcomes (7)

  • Rate of irregular menstrual cycle

    Irregular menstrual cycle

    6 month after working in the pandemic

  • Length of cycle

    Length of cycle (days)

    6 month after working in the pandemic

  • Rate of prolonged bleeding per cycle

    Duration of bleeding (day)

    6 month after working in the pandemic

  • Amount of flow

    Number of used tampons (pads) during bleeding

    6 month after working in the pandemic

  • Rate of dysmenorrhea

    Dysmenorrhea status

    6 month after working in the pandemic

  • 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

  • Recognizing a change in sexual life

    The participants will answer the survey by yes or no.

    6 month after working in the pandemic

Secondary Outcomes (3)

  • The number of differences in menstrual cycle length

    6 month after working in the pandemic

  • The number of differences in bleeding days

    6 month after working in the pandemic

  • The number of differences in the amount of flow

    6 month after working in the pandemic

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A COVID-19 survey in electronic or hard copy format for healthcare workers include physicians, nurses, emergency medical personnel, medical and nursing students, and administrative staff. The survey included questions about the respondents' demographic characteristics, changes in their practice during the pandemic period, and basic knowledge of COVID-19. Furthermore, questions evaluating fear and stress associated with the pandemic. In addition, the change in the character of the menstrual cycle and sexual life. The participants will be informed that the survey will be intended for research and that their participation will be anonymous. Participants did not have to answer all the questions in order to complete the survey.

You may qualify if:

  • 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.

You may not qualify if:

  • physicians who were retired or did not currently work in a designated COVID-19 hospital.
  • Physicians from other specialties
  • Physicians were on leave during the pandemic for various reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum university

Al Fayyum, 63514, Egypt

RECRUITING

MeSH Terms

Conditions

Menstruation DisturbancesAnxiety DisordersCOVID-19Occupational Stress

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

rehab A aboshama, Ass Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology Faculty of medicine

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 19, 2022

Study Start

April 1, 2022

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

May 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations