Menstrual ProblemNCT04806815
Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19
An observational study of Menstrual Problem and Covid19, run by Biruni University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menstrual Problem, Covid19, Fatigue
- What is being tested?
- A survey of 60 questions was created through the internet-based 'Google Forms surveys' site.
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2021to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: The study will include 200 volunteers, female individuals aged 18-45 who have had COVID-19.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Menstrual Problem, Covid19, Fatigue
- Being tested
- A survey of 60 questions was created through the internet-based 'Google Forms surveys' site.
- Keywords
- Menstrual Problem, Covid19, Fatigue
- Medical subject headings
- Menstruation Disturbances, COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A survey of 60 questions was created through the internet-based 'Google Forms surveys' site.Other
The following tests will be used together with the survey;
- Menstrual Symptom Questionnaire
- Fatigue Severity Scale
- Short Form Of Coronavirus Anxiety Scale
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start18 May 2021
- Primary completion30 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual ProblemStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket Akinci, Study director, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806815
- Sponsor's protocol ID
- 2021/47-45
- Status last verified
- Jun 2021
- First submitted
- 17 Mar 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19
- ClinicalTrials.gov ID
- NCT04806815
- Acronym / sponsor ID
- 2021/47-45
- Conditions
- Menstrual Problem, Covid19, Fatigue
- Keywords
- Menstrual Problem, Covid19, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study will include 200 volunteers, female individuals aged 18-45 who have had COVID-19.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
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.
2 secondary outcomes
Fatigue Severity Scale
Time frame: 1 day
Short Form Of Coronavirus Anxiety Scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket Akinci study director
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Problem and Covid19, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Symptom Questionnaire (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.