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Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806815
Recruitment Status : Completed
First Posted : March 19, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Buket AKINCI, Biruni University

Study Description
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Brief Summary:
The effects of COVID-19 on body systems and functions are still being investigated. ACE 2, which plays a key role in the entry of the COVID-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. The aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from COVID-19.

Condition or disease Intervention/treatment
Menstrual Problem Covid19 Fatigue Other: A survey of 60 questions was created through the internet-based 'Google Forms surveys' site.

Detailed Description:
The effects of COVID-19 on body systems and functions are still being investigated. ACE 2, which plays a key role in the entry of the COVID-19 virus into the cell, is also highly expressed in the ovary, uterus, vagina, and placenta in the female genital system, which can also pose a risk to female reproductive health. It has been examined that menstruation volume decreased or cycle lengthened in one-fifth of women who had COVID-19, and this condition was more intense in those who had severe COVID-19. Studies have shown that the possible effects of COVID-19 on the female genital system often remain theoretical hypotheses. In the literature, there was no study in which menstrual dysfunctions and secondary problems caused by the state of inactivity entering our lives during pandemic were discussed in a wide spectrum of women who had COVID-19. Therefore the aim of this study is to evaluate menstrual cycle-induced pain, fatigue and anxiety in women who suffered from COVID-19.
Study Design
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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19
Actual Study Start Date : May 18, 2021
Actual Primary Completion Date : May 30, 2021
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: A survey of 60 questions was created through the internet-based 'Google Forms surveys' site.

    The following tests will be used together with the survey;

    • Menstrual Symptom Questionnaire
    • Fatigue Severity Scale
    • Short Form Of Coronavirus Anxiety Scale

Outcome Measures
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Primary Outcome Measures :
  1. Menstrual Symptom Questionnaire [ Time Frame: 1 day ]
    This scale was developed to assess menstrual pain and symptoms. It is a five-point Likert-type scale consisting of 24 items. Participants will be asked to give a number between 1 (never) and 5 (always) to their menstrual symptoms. Total score will be calculated by taking the total score of the items in the scale. Increasing the average score indicates that the severity of menstrual symptoms increased.


Secondary Outcome Measures :
  1. Fatigue Severity Scale [ Time Frame: 1 day ]
    Each question in this scale consisting of Likert type questions: (1) I strongly disagree (2) I do not attend (3) I tend not to participate (4) I am indecisive (5) I tend to join (6) I participate (7) It is scored as I strongly agree. A score of 4 or higher on the questions indicates severe fatigue. The scoring of the scale, which consists of 9 questions in total, varies between 9 and 63, while a total score of 36 and above indicates fatigue.

  2. Short Form Of Coronavirus Anxiety Scale [ Time Frame: 1 day ]
    The questionnaire has a five-point Likert type rating and consists of 5 items. "0: none", "1: rarely, less than a day or two", "2: a few days", "3: more than 7 days," They will be asked to rank the options "," 4: almost every day during the last two weeks "according to the five elements of the scale.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female individuals aged 18-45 who have had COVID-19
Sampling Method:   Probability Sample
Study Population
The study will include 200 volunteers, female individuals aged 18-45 who have had COVID-19.
Criteria

Inclusion Criteria:

  • Being between the ages of 18 and 45,
  • PCR test result positive confirmed having COVID-19 infection,
  • Women had at least one period of Menstrual cycle after COVID-19
  • Being an Internet connection,
  • To be able to speak and write in Turkish.

Exclusion Criteria:

  • To be in the premenaposual/postmenopausal period (to be in the transition period to menopause or in the period after menopause.)
  • Having insufficient co-operation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806815


Locations
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Turkey
Biruni University
Istanbul, Turkey
Sponsors and Collaborators
Biruni University
Investigators
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Study Director: Buket Akinci Biruni University
More Information
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Responsible Party: Buket AKINCI, Associated Proffesor, Biruni University
ClinicalTrials.gov Identifier: NCT04806815    
Other Study ID Numbers: 2021/47-45
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Buket AKINCI, Biruni University:
Menstrual Problem
Covid19
Fatigue
Additional relevant MeSH terms:
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COVID-19
Fatigue
Menstruation Disturbances
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes