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

Sponsor
Biruni University (Other)
Overall Status
Completed
CT.gov ID
NCT04806815
Collaborator
(none)
180
1
14
391.3

Study Details

Study Description

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 Phase
  • 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

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 :
Jun 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Menstrual Symptom Questionnaire [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
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

Locations

Site City State Country Postal Code
1 Biruni University Istanbul Turkey

Sponsors and Collaborators

  • Biruni University

Investigators

  • Study Director: Buket Akinci, Biruni University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Buket AKINCI, Associated Proffesor, Biruni University
ClinicalTrials.gov Identifier:
NCT04806815
Other Study ID Numbers:
  • 2021/47-45
First Posted:
Mar 19, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Buket AKINCI, Associated Proffesor, Biruni University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021