- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04806815
Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19
29 juni 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
180
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Istanbul, Kalkon
- Biruni University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
N/A
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
The study will include 200 volunteers, female individuals aged 18-45 who have had COVID-19.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Menstrual Symptom Questionnaire
Tidsram: 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.
|
1 day
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fatigue Severity Scale
Tidsram: 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.
|
1 day
|
|
Short Form Of Coronavirus Anxiety Scale
Tidsram: 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.
|
1 day
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Buket Akinci, Biruni University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 maj 2021
Primärt slutförande (Faktisk)
30 maj 2021
Avslutad studie (Faktisk)
1 juni 2021
Studieregistreringsdatum
Först inskickad
17 mars 2021
Först inskickad som uppfyllde QC-kriterierna
18 mars 2021
Första postat (Faktisk)
19 mars 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juni 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juni 2021
Senast verifierad
1 juni 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021/47-45
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .