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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05954130
Other study ID # 04.11.2022/38
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source Cukurova University
Contact Sule GÖKYILDIZ SÜRÜCÜ, Prof.
Phone +90 (322) 338 64 84
Email gokyildizsule@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pregnancy is an important process with many changes in a woman's life. During this period, the sexual lives of couples may be affected due to anatomical, physiological and psychological changes. While sexual intercourse during pregnancy strengthens the harmony between spouses, emotional bond, and self-confidence of the woman, its role is important in terms of the continuation of the marriage. The development of technology in the world and in our country has led to an increase in the use of mobile devices. The emergence of telehealth and mobile applications with the Covid-19 pandemic has enabled individuals to access information whenever they want and more easily. The aim of this study was to determine the effect of mobile application support given to pregnant women for sexual health on sexual function and quality of sexual life. It is planned to develop a mobile application in this direction by preparing a guide, with the foresight that sexuality during pregnancy is not an easily expressed subject and that pregnant women and health workers need training materials. After the power analysis, it is aimed to reach a total of 70 people, 35 in the experimental group and 35 in the control group. Data will be collected with Personal Information Form, Female Sexual Function Index, Sexual Life Quality Scale and Qualitative Interview Form. Based on the developed guide and mobile application, training will be given to pregnant women in the first, second and third trimesters, and it is thought that the mobile application support specific to sexual health during pregnancy may contribute to increasing sexual function and sexual life quality.


Description:

This thesis study was designed to determine the effect of mobile application support given to pregnant women for sexual health on sexual function and quality of sexual life. In this thesis, it is planned to develop a mobile application in this direction by preparing a guide, with the foresight that sexuality during pregnancy is not an easily expressed subject and that pregnant women and health workers need training materials on this subject. Based on the developed guide and mobile application, it is thought that by providing continuous training to pregnant women, it can contribute to increasing women's sexual function and sexual life quality. Research Hypotheses - H0 a: Mobile application support for sexual health during pregnancy has no effect on sexual function. - H1 a: Mobile application support specific to sexual health during pregnancy has an effect on sexual function. - H0 b: The mobile application support for sexual health during pregnancy has no effect on the quality of sexual life. - H1 b: Mobile application support specific to sexual health during pregnancy has an effect on the quality of sexual life.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 31, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - In the first 3 months of pregnancy - Speaks and understands Turkish - Being able to read and write - Not having received prior education about sexuality during pregnancy Exclusion Criteria: - Having a risky pregnancy (under 18 years of age, having a chronic and psychiatric disease, etc.)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education
Sexual Health in Pregnancy

Locations

Country Name City State
Turkey Cukurova University Adana

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Female Sexual Function Index It was developed as a 19-item multidimensional scale to evaluate female sexual function. The scale assesses sexual problems or function in the last 4 weeks. In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain. Each item is scored from zero to 5. Accordingly, the highest raw score that can be obtained from the scale is 95.0, and the lowest raw score is 4.0. Change in sexual functions during pregnancy at 9 months
Secondary Sexual Quality of Life Scale The scale is easy to apply, six-point Likert type, which individuals can answer on their own, and consists of 18 items. It is expected that each item will be answered considering his sexual life in the last four weeks. In scoring the scale, each question is scored between 1-6. In this system, it will be scored as (1=Strongly Agree, 2=Strongly Agree, 3=Partly Agree, 4=Somewhat Disagree, 5=Strongly Agree, 6=Strongly Disagree). In this way, the range of points that can be obtained from the scale is between 18-108. Change in the quality of sexual life in 9 months of pregnancy
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