Sexual BehaviorNCT04374422
COVID-19 Pandemic and Female Sexual Behavior
An observational study of Sexual Behavior and COVID, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
World Health Organization declared new SARS-CoV-2 infection a pandemic, and many states enacted strict, rules such as border closures, transportation restrictions and quarantine.Many studies in the literature have described the relationship between mass disasters and female sexual behavior, but none have investigated… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, COVID
- What is being tested?
- fsfi survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2020to 12 Apr 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: From February 2018 to September 2019. For each participant, detailed medical history was obtained, including age, body mass index (BMI), education and income level, presence of comorbidities and the number of previous deliveries. Other details noted were menstrual status of patients, frequency of sexual intercourse and desire for fertility. All patients were asked to fill out the Female Sexual Function Index (FSFI) form. Patients' data were recorded in the electronic data system, prospectively. To identify the effect of SARS-CoV-2 pandemic on female sexual behavior, the investigators conducted an observational study to compare the frequency of sexual intercourse, desire for fertility, FSFI score, contraception type and presence of vaginal infection between pandemic era (March 11th and April 12th 2020) and 6-12 months prior to the pandemic.
Who may be able to join
- married
- above 18 yo
- premenopausal status
Who cannot join
- urinary incontinence
- history of gynecologic operation
- malignancy
- psychiatric or neurologic disease diagnosis
- being infected by HBV HCV or HIV
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, 34104
About this study
Official title: Effect of SARS- COVID-19 Pandemic on Female Sexual Behavior
World Health Organization declared new SARS-CoV-2 infection a pandemic, and many states enacted strict, rules such as border closures, transportation restrictions and quarantine.Many studies in the literature have described the relationship between mass disasters and female sexual behavior, but none have investigated the effect of SARS-CoV-2 pandemic on women's sexual attitude. The aim of this study is therefore to evaluate the effect of SARS-CoV-2 pandemic on female sexual behavior.
Read the detailed description
Coronaviruses are a group of RNA viruses that affect mainly the respiratory system and cause the common cold, fever, and coughs in mammals and birds. However, in some cases, coronaviruses are associated with more serious and lethal conditions, such as pneumonia, bronchitis, and severe acute respiratory syndrome. A novel coronavirus (SARS-CoV-2) originating from Wuhan, China led to a global health crisis. At the time of writing, SARS-CoV-2 infected more than two million, resulting in almost 180.000 deaths. World Health Organization declared new SARS-CoV-2 infection a pandemic, and many states enacted strict, rules such as border closures, transportation restrictions, and quarantine.
The term 'sexual behavior' encompasses a large spectrum of actions in which humans present their sexuality. Previous reports have analyzed the effect of mass disasters on female sexual behavior.
Many studies in the literature have described the relationship between mass disasters and female sexual behavior, but none have investigated the effect of the SARS-CoV-2 pandemic on women's sexual attitude. The aim of this study is therefore to evaluate the effect of the SARS-CoV-2 pandemic on female sexual behavior.
- Conditions
- Sexual Behavior, COVID
- Being tested
- fsfi survey
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fsfi surveyBehavioural
sexual behavior Questionaire
| Study group | Role | What they receive |
|---|---|---|
| 1 | study group pre-pandemic time interval Receives: Behavioral: fsfi survey | |
| 2 | same population during pandemic Receives: Behavioral: fsfi survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSFI (Female Sexual Function Index)SCORE difference
the FSFI SCORE difference between pre and during pandemic
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start10 Apr 2020
- Primary completion12 Apr 2020
- Study completion12 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374422
- Sponsor's protocol ID
- AcibademU cov
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: in case of request
Publications
Liao X, Wang B, Kang Y. Novel coronavirus infection during the 2019-2020 epidemic: preparing intensive care units-the experience in Sichuan Province, China. Intensive Care Med. 2020 Feb;46(2):357-360. doi: 10.1007/s00134-020-05954-2. Epub 2020 Feb 5. No abstract available.
PubMed 32025779Liu S, Han J, Xiao D, Ma C, Chen B. A report on the reproductive health of women after the massive 2008 Wenchuan earthquake. Int J Gynaecol Obstet. 2010 Feb;108(2):161-4. doi: 10.1016/j.ijgo.2009.08.030. Epub 2009 Nov 4.
PubMed 19892335
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SARS- COVID-19 Pandemic on Female Sexual Behavior
- ClinicalTrials.gov ID
- NCT04374422
- Acronym / sponsor ID
- AcibademU cov
- Conditions
- Sexual Behavior, COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 12 Apr 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 5 May 2020 (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.
World Health Organization declared new SARS-CoV-2 infection a pandemic, and many states enacted strict, rules such as border closures, transportation restrictions and quarantine.Many studies in the literature have described the relationship between mass disasters and female sexual behavior, but none have investigated the effect of SARS-CoV-2 pandemic on women's sexual attitude. The aim of this study is therefore to evaluate the effect of SARS-CoV-2 pandemic on female sexual behavior.
Detailed description
Coronaviruses are a group of RNA viruses that affect mainly the respiratory system and cause the common cold, fever, and coughs in mammals and birds. However, in some cases, coronaviruses are associated with more serious and lethal conditions, such as pneumonia, bronchitis, and severe acute respiratory syndrome. A novel coronavirus (SARS-CoV-2) originating from Wuhan, China led to a global health crisis. At the time of writing, SARS-CoV-2 infected more than two million, resulting in almost 180.000 deaths. World Health Organization declared new SARS-CoV-2 infection a pandemic, and many states enacted strict, rules such as border closures, transportation restrictions, and quarantine.
The term 'sexual behavior' encompasses a large spectrum of actions in which humans present their sexuality. Previous reports have analyzed the effect of mass disasters on female sexual behavior.
Many studies in the literature have described the relationship between mass disasters and female sexual behavior, but none have investigated the effect of the SARS-CoV-2 pandemic on women's sexual attitude. The aim of this study is therefore to evaluate the effect of the SARS-CoV-2 pandemic on female sexual behavior.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: fsfi surveystudy group pre-pandemic time interval |
| 2 | – | Behavioral: fsfi surveysame population during pandemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From February 2018 to September 2019. For each participant, detailed medical history was obtained, including age, body mass index (BMI), education and income level, presence of comorbidities and the number of previous deliveries. Other details noted were menstrual status of patients, frequency of sexual intercourse and desire for fertility. All patients were asked to fill out the Female Sexual Function Index (FSFI) form. Patients' data were recorded in the electronic data system, prospectively. To identify the effect of SARS-CoV-2 pandemic on female sexual behavior, the investigators conducted an observational study to compare the frequency of sexual intercourse, desire for fertility, FSFI score, contraception type and presence of vaginal infection between pandemic era (March 11th and April 12th 2020) and 6-12 months prior to the pandemic.
Key inclusion criteria (3 listed)
- married
- above 18 yo
- premenopausal status
Key exclusion criteria (5 listed)
- urinary incontinence
- history of gynecologic operation
- malignancy
- psychiatric or neurologic disease diagnosis
- being infected by HBV HCV or HIV
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 |
|---|---|---|
| fsfi surveysexual behavior Questionaire | Behavioural | 1, 2 |
Primary outcome
FSFI (Female Sexual Function Index)SCORE difference
Time frame: 1 year
the FSFI SCORE difference between pre and during pandemic
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 5 May 2020.
- Results publication: PubMed 32025779Liao X, Wang B, Kang Y. Novel coronavirus infection during the 2019-2020 epidemic: preparing intensive care units-the experience in Sichuan Province, China. Intensive Care Med. 2020 Feb;46(2):357-360. doi: 10.1007/s00134-020-05954-2. Epub 2020 Feb 5. No abstract available.
- Results publication: PubMed 19892335Liu S, Han J, Xiao D, Ma C, Chen B. A report on the reproductive health of women after the massive 2008 Wenchuan earthquake. Int J Gynaecol Obstet. 2010 Feb;108(2):161-4. doi: 10.1016/j.ijgo.2009.08.030. Epub 2009 Nov 4.
- Individual participant dataSharing planned: Undecided. in case of request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sexual Behavior and COVID, run by Acibadem 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 3 inclusion and 5 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 5 May 2020. 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?
FSFI (Female Sexual Function Index)SCORE difference (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04374422, which also lists 2 linked publications.
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 5 May 2020.