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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806815
• Other study ID #: 2021/47-45
• Status: Completed
• Start date: May 18, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 1, 2021
• Est. primary completion date: May 30, 2021
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Fatigue
• Menstrual Problem
• Menstruation Disturbances

Intervention

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

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual Symptom Questionnaire	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.	1 day
Secondary	Fatigue Severity Scale	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.	1 day
Secondary	Short Form Of Coronavirus Anxiety Scale	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.	1 day