Clinical trial NCT04413058: Menstrual Cycle Characteristics of Healthcare Professionals
Official title: Menstrual Cycle Characteristics of Healthcare Professionals at Covid 19 Pandemic Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Irregularity
Covid 19
Keywords: health care professionals
menstrual cycle
Covid 19
Pandemia
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy female healthcare workers at Covid 19 pandemic hospital

Brief summary: The Covid-19 pandemic has impacted healthcare workers physically and psychologically. The aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. The aim of this study is to investigate whether there is an association between covid infection and menstrual cycle changes.

Detailed description: The Covid-19 pandemic has impacted healthcare workers physically and psychologically. Healthcare workers have ben required to work under stressful conditions and take difficult decisions involving ethical implications. Increasing work demands on healthcare professionals conflict with their duties to family and friends, which causes psychological stress. All of these factors may negatively affect their menstrual cycle.

The aim of this study is to examine whether there is a change in menstrual cycle characteristics during pandemia. Second aim is to investigate whether there is an association between Covid 19 infection and menstrual cycle changes.

This cross-sectional study is conducted with healthy female participants who are working at Haydarpasa Numune Research and Training Hospital in Turkey. The researcher investigates the characteristics of menstrual cycle in female healthy workers employed in Covid 19 pandemic inpatient and outpatient clinics. The participants who are sure about their pertinent information are enrolled in the study. The exclusion criteria includes pregnancy, history of hysterectomy, oophorectomy, diseases like Asherman's syndrome and also history of endocrine disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral contraceptive use, malignancy, primary amenorrhea, menopause and lactation.

After informed consent, detailed information is collected using structured questionnaires about their reproductive factors and menstrual cycles by direct interviews. The questionnaire contains questions about age, work experience, marital status, height, weight, working hours, use of medication, menstrual cycle characteristics (including cycle duration, duration and amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and dysmenorrhea. Also, the difference in menstrual cycle characteristics between covid positive and negative healthcare professionals is investigated.

Eligibility criteria: Inclusion Criteria:

* Working at Covid 19 Pandemic Hospital
* Being at between 18 and 47 years old
* Having menstruation

Exclusion Criteria:

* Oral contraceptive users
* Pregnants
* Having malignancy
* Having primary amenorrhea
* Being at menopause
* Lactation

Primary outcomes:
measure: Rate of irregular menstrual cycle
timeFrame: 1 month after starting to work at pandemic clinic
measure: Length of cycle
timeFrame: 1 month after starting to work at pandemic clinic
measure: Rate of prolonged bleeding
timeFrame: 1 month after starting to work at pandemic clinic
measure: Amount of flow
timeFrame: 1 month after starting to work at pandemic clinic
measure: Rate of dysmenorrhea
timeFrame: 1 month after starting to work at pandemic clinic
Secondary outcomes:
measure: The number of difference in menstrual cycle length
timeFrame: Up to 1 month after covid infection
measure: The number of difference in bleeding days
timeFrame: Up to 1 month after covid infection
measure: The number of difference in amount of flow
timeFrame: Up to 1 month after covid infection
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
References:
citation: Attarchi M, Darkhi H, Khodarahmian M, Dolati M, Kashanian M, Ghaffari M, Mirzamohammadi E, Mohammadi S. Characteristics of menstrual cycle in shift workers. Glob J Health Sci. 2013 Feb 28;5(3):163-72. doi: 10.5539/gjhs.v5n3p163.
citation: Moen BE, Baste V, Morken T, Alsaker K, Pallesen S, Bjorvatn B. Menstrual characteristics and night work among nurses. Ind Health. 2015;53(4):354-60. doi: 10.2486/indhealth.2014-0214. Epub 2015 Apr 24.
citation: Ok G, Ahn J, Lee W. Association between irregular menstrual cycles and occupational characteristics among female workers in Korea. Maturitas. 2019 Nov;129:62-67. doi: 10.1016/j.maturitas.2019.07.019. Epub 2019 Aug 2.
citation: Wan GH, Chung FF. Working conditions associated with ovarian cycle in a medical center nurses: a Taiwan study. Jpn J Nurs Sci. 2012 Jun;9(1):112-8. doi: 10.1111/j.1742-7924.2011.00191.x. Epub 2011 Sep 16.