- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05954130
The Effect of Web-Based Education Specific to Sexual Health During Pregnancy on Sexual Life
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Adana, Turkey
- Çukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile Application Support Specific to Sexual Health in Pregnancy
The training module will consist of 3 sessions.
The first session will last 1 hour, with 45 minutes of interactive lecture and 15 minutes of question and answer.
The second and third sessions will last 1 hour, with 45 minutes of interactive narration and 15 minutes of qualitative interviews.
Module sessions will have a dynamic structure that takes into account the needs of the pregnant woman in her trimester.
The content of the training sessions will be structured on the following topics.
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Sexual Health in Pregnancy
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No Intervention: control
No training will be given to the pregnant women in the control group who accepted to participate in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female Sexual Function Index
Time Frame: Change in sexual functions during pregnancy at 9 months
|
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.
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Change in sexual functions during pregnancy at 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Quality of Life Scale
Time Frame: Change in the quality of sexual life in 9 months of pregnancy
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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.
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Change in the quality of sexual life in 9 months of pregnancy
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Şule GÖKYILDIZ SÜRÜCÜ, Prof., gokyildizsule@gmail.com
- Principal Investigator: Emel SALCAN, Msc.Midwife, emelers@hotmail.com
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 04.11.2022/38
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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