Sexual Functions and Covid-19
Primary Purpose
Covid19, Sexual Behavior
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
Sponsored by
About this trial
This is an interventional other trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
- being sexually active
Exclusion Criteria:
- having psychiatric disease
- having any malignity
- having endometriosis
- having a gynecologic surgery history
- having a previous sexual dysfunction
Sites / Locations
- Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
50 women previously diagnosed with mild - medium Covid-19 and had ambulatory care
51 women having no Covid-19 history
Arm Description
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
Outcomes
Primary Outcome Measures
Sexual function assesment of women previously diagnosed with mild - medium Covid-19 and comparision of results with helath women
Sexual function assesment of women is done by using Female Sexual Functioning Index (FSFI).
Secondary Outcome Measures
Full Information
NCT ID
NCT05018065
First Posted
August 23, 2021
Last Updated
August 24, 2021
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05018065
Brief Title
Sexual Functions and Covid-19
Official Title
Evaluation of Women's Sexual Functions After Having Covid-19
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Sexual health is one the important components of life quality. The aim of this study is to compare sexual dysfunction of women who survived Covid-19 and who didn't undergo Covid-19.
Detailed Description
With identifying a new type of coronavirus, the infection disease known as Coronavirus disease-2019 (Covid-19) is still effective worldwide. Within the frame of the description that the health is "a complete physical, mental and social welfare," many physical and mental modality may be expected due to the pandemic and the measures against pandemic. Among them, sexual health is one of the basic indicative factors of human welfare. There are few data on sexual dysfunctions from the previous clinic pandemic experiences. From the very early stages of Covid-19 pandemic, health systems and researches focused on mortalities and short-term morbidities. Although there are similar studies about effects of pandemic on sexual behaviors of general community, there is no comparative study about the effects on sexual functions of women survived from Covid-19 and women having no Covid-19 history, yet. This study aims to compare women survived from Covid-19 and women having no Covid-19 history and having similar characteristics in terms of sexual dysfunctions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Sexual Behavior
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 women previously diagnosed with mild - medium Covid-19 and had ambulatory care
Arm Type
Active Comparator
Arm Description
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
Arm Title
51 women having no Covid-19 history
Arm Type
Active Comparator
Arm Description
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
Intervention Type
Behavioral
Intervention Name(s)
Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)
Intervention Description
sexual dysfunction assesment
Primary Outcome Measure Information:
Title
Sexual function assesment of women previously diagnosed with mild - medium Covid-19 and comparision of results with helath women
Description
Sexual function assesment of women is done by using Female Sexual Functioning Index (FSFI).
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
being sexually active
Exclusion Criteria:
having psychiatric disease
having any malignity
having endometriosis
having a gynecologic surgery history
having a previous sexual dysfunction
Facility Information:
Facility Name
Saglık Bilimleri University Istanbul Gaziosmanpa Trainig and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Sexual Functions and Covid-19
We'll reach out to this number within 24 hrs