Sexual BehaviorNCT05954130
The Effect of Web-Based Education Specific to Sexual Health During Pregnancy on Sexual Life
A study testing Education in people with Sexual Behavior, run by Cukurova University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Having a risky pregnancy (under 18 years of age, having a chronic and psychiatric disease, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sexual Behavior
- Being tested
- Education
- Keywords
- pregnancy, sexual life, education
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Sexual Health in Pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application Support Specific to Sexual Health in Pregnancy | Experimental | 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. Receives: Other: Education |
| control | No intervention | No training will be given to the pregnant women in the control group who accepted to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in sexual functions during pregnancy at 9 months
Secondary outcomes (1)
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.
Measured: Change in the quality of sexual life in 9 months of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start9 Sep 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental and control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule Gokyildiz Surucu, Cukurova University
- Investigators
- Şule GÖKYILDIZ SÜRÜCÜ, Prof., Study director, gokyildizsule@gmail.comEmel SALCAN, Msc.Midwife, Principal investigator, emelers@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954130
- Sponsor's protocol ID
- 04.11.2022/38
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Education Specific to Sexual Health During Pregnancy on Sexual Life
- ClinicalTrials.gov ID
- NCT05954130
- Acronym / sponsor ID
- 04.11.2022/38
- Conditions
- Sexual Behavior
- Keywords
- pregnancy, sexual life, education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 20 Jul 2023 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- experimental and control
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Support Specific to Sexual Health in Pregnancy | Experimental | Other: EducationThe 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. |
| control | No intervention | –No training will be given to the pregnant women in the control group who accepted to participate in the study. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Having a risky pregnancy (under 18 years of age, having a chronic and psychiatric disease, etc.)
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 |
|---|---|---|
| EducationSexual Health in Pregnancy | Other | Mobile Application Support Specific to Sexual Health in Pregnancy |
Primary outcome
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.
1 secondary outcome
Sexual Quality of Life Scale
Time frame: Change in the quality of sexual life in 9 months of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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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.
Şule GÖKYILDIZ SÜRÜCÜ, Prof. study director
gokyildizsule@gmail.com
Emel SALCAN, Msc.Midwife principal investigator
emelers@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Sexual Behavior, run by Cukurova 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 4 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 17 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Female Sexual Function Index (time frame: Change in sexual functions during pregnancy at 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2025.