PregnancyNCT05790967
The Effect of Sex Education on Sexuality of Pregnant Women
A study testing Sexual Education in people with Pregnancy, run by NESLİHAN YILMAZ SEZER at 1 site in Turkey (Türkiye).
Trial summary
Aim: In this study, it is aimed to determine the effect of sexual education given to pregnant women on attitudes towards sexuality and sexual response during pregnancy. The study will be carried out in two different groups. 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
- Pregnancy
- What is being tested?
- Sexual Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2023to 29 Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- Primigravida
- Having a singleton pregnancy
- Being between 14 -22 weeks of pregnancy
- Living with their partner
Who cannot join
- Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
- Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
- Use of psychiatric drugs
- Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
- Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
- Use of psychiatric drugs such as antidepressants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Cebeci Hospital
Ankara, Mamak, 06620
About this study
Official title: The Effect of Sex Education on the Sexual Response and Attitudes Towards Sexuality of Pregnant Women
Aim: In this study, it is aimed to determine the effect of sexual education given to pregnant women on attitudes towards sexuality and sexual response during pregnancy.
The study will be carried out in two different groups. After the women are evaluated in terms of eligibility criteria for the research, the eligible pregnant women will be informed about the research and written informed consent will be obtained from those who accept. Random distribution of pregnant women to study groups will be made using the Block Randomization method. The following applications will be made to the groups.
Read more
Education Group: Women in the experimental group will be given education on sexual life during pregnancy. Before the training, preliminary data will be collected and then the participants will be given two hours of individual and face-to-face training.
At the end of the training, homework will be given to pregnant women to practice at home, including "sharing their sexual feelings and thoughts with their spouse, sharing problems and concerns about sexuality during pregnancy, and using alternative ways other than sexual intercourse. In addition, a "Sexual Life in Pregnancy Information Booklet" will be given, and they will be asked to read the information in the booklet and share it with their spouses. After 4 weeks, the data sheets will be applied again.
Control Group: Patients in the control group of the study will not be subjected to any treatment other than the routine procedure. Data collection forms will be applied to the patients in the control group at the beginning of the study and after 4 weeks.
- Conditions
- Pregnancy
- Being tested
- Sexual Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual EducationOther
Women in the experimental group will be given education on sexual life during pregnancy. Before the training, preliminary data will be collected and then the participants will be given two hours of individual and face-to-face training.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | Not described Receives: Other: Sexual Education |
| CONTROL | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sexual response
Pregnancy Sexual Response Inventory which evaluates sexual activity and sexuality problems in pregnant women, consists of two parts and a total of 38 items. The total score ranges from 0 to 100, with scores between 0-25 as "Very bad", between 25-50 as "Bad", between 50-75 as "Good" and between 75-100 as "Excellent".
Measured: baseline, four weeks later
Attitude Scale toward Sexuality during Pregnancy Change:
Attitude towards Sexuality in Pregnancy consists of 34 items and 3 sub-dimensions. The increase in the total score obtained from the scale indicates that the attitudes towards sexuality during pregnancy are positive, and the decrease in the total score indicates that the attitudes towards sexuality during pregnancy are negative. In addition, the cut-off point of the scale was determined as 111.5.
Measured: baseline, four weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start27 Mar 2023
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- NESLİHAN YILMAZ SEZER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NESLİHAN YILMAZ SEZER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790967
- Sponsor's protocol ID
- 20/189
- Status last verified
- Nov 2023
- First submitted
- 17 Mar 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sex Education on the Sexual Response and Attitudes Towards Sexuality of Pregnant Women
- ClinicalTrials.gov ID
- NCT05790967
- Acronym / sponsor ID
- 20/189
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- NESLİHAN YILMAZ SEZERUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 30 Mar 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.
Aim: In this study, it is aimed to determine the effect of sexual education given to pregnant women on attitudes towards sexuality and sexual response during pregnancy.
The study will be carried out in two different groups. After the women are evaluated in terms of eligibility criteria for the research, the eligible pregnant women will be informed about the research and written informed consent will be obtained from those who accept. Random distribution of pregnant women to study groups will be made using the Block Randomization method. The following applications will be made to the groups.
Education Group: Women in the experimental group will be given education on sexual life during pregnancy. Before the training, preliminary data will be collected and then the participants will be given two hours of individual and face-to-face training.
At the end of the training, homework will be given to pregnant women to practice at home, including "sharing their sexual feelings and thoughts with their spouse, sharing problems and concerns about sexuality during pregnancy, and using alternative ways other than sexual intercourse. In addition, a "Sexual Life in Pregnancy Information Booklet" will be given, and they will be asked to read the information in the booklet and share it with their spouses. After 4 weeks, the data sheets will be applied again.
Control Group: Patients in the control group of the study will not be subjected to any treatment other than the routine procedure. Data collection forms will be applied to the patients in the control group at the beginning of the study and after 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Other: Sexual Education |
| CONTROL | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primigravida
- Having a singleton pregnancy
- Being between 14 -22 weeks of pregnancy
- Living with their partner
Key exclusion criteria (6 listed)
- Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
- Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
- Use of psychiatric drugs
- Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
- Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
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 |
|---|---|---|
| Sexual EducationWomen in the experimental group will be given education on sexual life during pregnancy. Before the training, preliminary data will be collected and then the participants will be given two hours of individual and face-to-face training. | Other | Education Group |
Primary outcome
Change in sexual response
Time frame: baseline, four weeks later
Pregnancy Sexual Response Inventory which evaluates sexual activity and sexuality problems in pregnant women, consists of two parts and a total of 38 items. The total score ranges from 0 to 100, with scores between 0-25 as "Very bad", between 25-50 as "Bad", between 50-75 as "Good" and between 75-100 as "Excellent".
Attitude Scale toward Sexuality during Pregnancy Change:
Time frame: baseline, four weeks later
Attitude towards Sexuality in Pregnancy consists of 34 items and 3 sub-dimensions. The increase in the total score obtained from the scale indicates that the attitudes towards sexuality during pregnancy are positive, and the decrease in the total score indicates that the attitudes towards sexuality during pregnancy are negative. In addition, the cut-off point of the scale was determined as 111.5.
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 15 Nov 2023.
- Individual participant dataSharing planned: No
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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?
A study testing Sexual Education in people with Pregnancy, run by NESLİHAN YILMAZ SEZER 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 6 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 15 Nov 2023. 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?
Change in sexual response (time frame: baseline, four weeks later). The study lists 2 primary outcomes in all. 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 15 Nov 2023.