- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04806815
Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19
29. juni 2021 opdateret af: Buket AKINCI, Biruni University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
180
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul, Kalkun
- Biruni University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The study will include 200 volunteers, female individuals aged 18-45 who have had COVID-19.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Menstrual Symptom Questionnaire
Tidsramme: 1 day
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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.
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1 day
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fatigue Severity Scale
Tidsramme: 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.
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1 day
|
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Short Form Of Coronavirus Anxiety Scale
Tidsramme: 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.
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1 day
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Buket Akinci, Biruni University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. maj 2021
Primær færdiggørelse (Faktiske)
30. maj 2021
Studieafslutning (Faktiske)
1. juni 2021
Datoer for studieregistrering
Først indsendt
17. marts 2021
Først indsendt, der opfyldte QC-kriterier
18. marts 2021
Først opslået (Faktiske)
19. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021/47-45
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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