PregnancyNCT06762301
The Effect of Sexual Education-Counseling According to PLISSIT Model of Couples' Sexual Functions During Pregnancy and Postpartum
A study testing sexual education and counseling and Routine clinical care in people with Pregnancy and Postpartum Period, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Sexuality is a natural part of human life at every stage of life. It is a multidimensional phenomenon influenced by biological, psychological, social, interpersonal and cultural factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Postpartum Period, Sexual Dysfunction
- What is being tested?
- sexual education and counseling and Routine clinical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2023to 30 Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For a pregnant woman;
- A woman who had just received the result of a pregnancy test and was referred to the family health center due to a positive pregnancy,
- Who wants the pregnancy to continue,
- In the first 6-8 gh. of gestation,
- FSFI cut-off value for pre/conceptional period with a total score ≤26.55,
- The one with a single, healthy fetus,
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- Has a sexual partner and has an active sexual life,
- For the pregnant woman and her partner/partner;
- Educated enough to understand what they read and answer questions,
- Do not have chronic diseases that may affect sexual health (cancer, diabetes, hypertension, hypercholesterolemia, heart disease, atherosclerosis, chronic pulmonary and hepatic diseases, chronic renal failure, mental disorder, etc.) or continuous drug use (antihypertensive, diuretic, lipid-lowering agent, H2 receptor antagonist, antihistamine, anticholinergic, chemotherapeutic agent, anticonvulsant, antidepressant, antipsychotic, narcotic, sedative, etc.) and
- Pregnant women and their spouses who volunteered to participate in the study
Who cannot join
- Not planning to continue the pregnancy / planning to terminate the pregnancy,
- Who has completed the first trimester of pregnancy,
- FSFI cut-off value for pre/conceptional period with a total score >26.55
- No active sex life,
- With language problems,
- Not educated enough to understand what they read and answer questions,
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- Chronic illness or medication that may affect sexuality,
- Those who did not want to participate in the study and
- Pregnant women and their partners who wanted to leave the study voluntarily at any stage of the study / who felt uncomfortable with the questions asked during the study, or who discontinued the study
Trial locations and contacts
1 site in 1 country.
About this study
Sexuality is a natural part of human life at every stage of life. It is a multidimensional phenomenon influenced by biological, psychological, social, interpersonal and cultural factors. Pregnancy is an extremely important process that occurs as a result of a sexual relationship and affects the lives of the woman and the couple.
Many studies in the literature clearly show that sexual life is affected during pregnancy and postpartum period. In this context, it is stated that sexual health assessment, sexual education and counseling in pregnant/couples can be addressed in the early stages of pregnancy to reduce the anxiety of couples and the likelihood of sexual problems. It is important to evaluate sexual health during pregnancy and postpartum and to provide counseling and support in line with the results. In order to evaluate pregnancy and postpartum processes appropriately, the sexual history of women/couples should be defined. Therefore, it is important to learn the pre-pregnancy history of women/couples regarding their sexual activities and current sexual functions, to determine whether they experience sexual dysfunction during pregnancy or postpartum, and to examine its role in pregnancy and postpartum period, if any.
Read the detailed description
Many studies in the literature clearly show that sexual life is affected during pregnancy and postpartum period. In this context, it is stated that sexual health assessment, sexual education and counseling in pregnant/couples can be addressed in the early stages of pregnancy to reduce the anxiety of couples and the likelihood of sexual problems. It is important to evaluate sexual health during pregnancy and postpartum and to provide counseling and support in line with the results. In order to evaluate pregnancy and postpartum processes appropriately, the sexual history of women/couples should be defined. Therefore, it is important to learn the pre-pregnancy history of women/couples regarding their sexual activities and current sexual functions, to determine whether they experience sexual dysfunction during pregnancy or postpartum, and to examine its role in pregnancy and postpartum period, if any.In this context, talking to couples about their sexuality and providing sexual health counseling appropriate to their needs provides an opportunity to develop safe sexual health behaviors. In this process, the aim of nurses is to strengthen the sexual health of couples, encourage them to express their sexual problems, determine the causes and characteristics of sexual problems, and make interventions for the problems identified. The nurse can plan and carry out preventive interventions for the sexual health of couples, improve the ability to express sexual life, counsel and refer for early diagnosis and treatment of existing problems. It is recommended to use a model that will be useful in the training and counseling services provided by nurses and it is stated that it will increase the effectiveness of the service provided.It is emphasized that the PLISSIT model is a useful tool for nurses on sexuality and sexual health. The PLISSIT model supports the counseling role by assessing the individual in collaboration, understanding and respecting their decisions. By using the first three phases of this model, which can be applied at any time and in different situations, 80-90% of sexual problems can be solved on average. Recent studies in the literature with this model show that the training and counseling provided according to the models have positive effects on sexual problems.
In the studies conducted, it was observed that sexual education and counseling processes did not include pregnant women and their partners, and there were no studies evaluating the long-term effects on the sexual lives of couples. In this study, it was aimed to determine the effect of sexual education-counseling given to couples with sexual dysfunction in the preconceptional period in accordance with the PLISSIT model on their sexual functions during pregnancy and postpartum period.
- Being tested
- sexual education and counseling, Routine clinical care
- Keywords
- pregnancy, postpartum period, sexual dysfunction, PLISSIT model, sexual counselling
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexual education and counselingBehavioural
After the initial evaluation, pregnant women who will be included in the study group will be given an appointment for 1 week later, they will be asked to come with their partners and couples will be given sexual education and counseling in line with the PLISSIT model. After the initial evaluation, couples will be interviewed in the 1st, 2nd and 3rd trimesters, their sexuality since the previous evaluation according to the PLISSIT model, their problems, if any, will be discussed and short counseling will be given if necessary. In the first 4 weeks after delivery, couples in the study group will receive sexual education and counseling for the postpartum period in line with the PLISSIT model. They will be interviewed at the 3rd and 6th month after delivery and their postpartum sexuality and problems, if any, will be discussed and the sexual functions of the couples for the last 4 weeks will be evaluated.
Routine clinical careOther
Control Group
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | After the initial evaluation, pregnant women who will be included in the study group will be given an appointment for 1 week later, they will be asked to come with their partners and couples will be given sexual education and counseling in line with the PLISSIT model.
After the initial evaluation, couples will be interviewed in the 1st, 2nd and 3rd trimesters, their sexuality since the previous evaluation according to the PLISSIT model, their problems, if any, will be discussed and short counseling will be given if necessary.
In the first 4 weeks after delivery, couples in the study group will receive sexual education and counseling for the postpartum period in line with the PLISSIT model.
They will be interviewed at the 3rd and 6th month after delivery and their postpartum sexuality and problems, if any, will be discussed and the sexual functions of the couples for the last 4 weeks will be evaluated. Receives: Behavioral: sexual education and counseling |
| Control Group | Other | Routine clinical care Receives: Other: Routine clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI)
According to the Female Sexual Function Index (FSFI) cut-off value to be applied to each sampled pregnant woman at the first encounter, pregnant women with a total score ≤26.55, that is, pregnant women with sexual dysfunction, will be identified.
Measured: 15 Months
The International Erectile Function Evaluation Form (IIEF)
The International Erectile Function Evaluation Form (IIEF) is evaluated in 5 categories in terms of erectile function. These are; severe erectile dysfunction (ED) score (6-10), moderate ED score (11-16), moderate-mild ED score (17-21), mild ED score (22-25), no ED (26-30) (Cappelleri et al., 1999). The scores that can be obtained as a result of IIEF evaluation are between 5-75. Cut-off value is not specified.
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Mar 2023
- Primary completion30 Oct 2024
- Study completion30 Jun 2025 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Özlem BAKAN DEMİREL, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762301
- Sponsor's protocol ID
- MARMARAU-SBE-OBD-01
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Education-Counseling According to PLISSIT Model of Couples' Sexual Functions During Pregnancy and Postpartum
- ClinicalTrials.gov ID
- NCT06762301
- Acronym / sponsor ID
- MARMARAU-SBE-OBD-01
- Keywords
- pregnancy, postpartum period, sexual dysfunction, PLISSIT model, sexual counselling
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
Sexuality is a natural part of human life at every stage of life. It is a multidimensional phenomenon influenced by biological, psychological, social, interpersonal and cultural factors. Pregnancy is an extremely important process that occurs as a result of a sexual relationship and affects the lives of the woman and the couple.
Many studies in the literature clearly show that sexual life is affected during pregnancy and postpartum period. In this context, it is stated that sexual health assessment, sexual education and counseling in pregnant/couples can be addressed in the early stages of pregnancy to reduce the anxiety of couples and the likelihood of sexual problems. It is important to evaluate sexual health during pregnancy and postpartum and to provide counseling and support in line with the results. In order to evaluate pregnancy and postpartum processes appropriately, the sexual history of women/couples should be defined. Therefore, it is important to learn the pre-pregnancy history of women/couples regarding their sexual activities and current sexual functions, to determine whether they experience sexual dysfunction during pregnancy or postpartum, and to examine its role in pregnancy and postpartum period, if any.
Detailed description
Many studies in the literature clearly show that sexual life is affected during pregnancy and postpartum period. In this context, it is stated that sexual health assessment, sexual education and counseling in pregnant/couples can be addressed in the early stages of pregnancy to reduce the anxiety of couples and the likelihood of sexual problems. It is important to evaluate sexual health during pregnancy and postpartum and to provide counseling and support in line with the results. In order to evaluate pregnancy and postpartum processes appropriately, the sexual history of women/couples should be defined. Therefore, it is important to learn the pre-pregnancy history of women/couples regarding their sexual activities and current sexual functions, to determine whether they experience sexual dysfunction during pregnancy or postpartum, and to examine its role in pregnancy and postpartum period, if any.In this context, talking to couples about their sexuality and providing sexual health counseling appropriate to their needs provides an opportunity to develop safe sexual health behaviors. In this process, the aim of nurses is to strengthen the sexual health of couples, encourage them to express their sexual problems, determine the causes and characteristics of sexual problems, and make interventions for the problems identified. The nurse can plan and carry out preventive interventions for the sexual health of couples, improve the ability to express sexual life, counsel and refer for early diagnosis and treatment of existing problems. It is recommended to use a model that will be useful in the training and counseling services provided by nurses and it is stated that it will increase the effectiveness of the service provided.It is emphasized that the PLISSIT model is a useful tool for nurses on sexuality and sexual health. The PLISSIT model supports the counseling role by assessing the individual in collaboration, understanding and respecting their decisions. By using the first three phases of this model, which can be applied at any time and in different situations, 80-90% of sexual problems can be solved on average. Recent studies in the literature with this model show that the training and counseling provided according to the models have positive effects on sexual problems.
In the studies conducted, it was observed that sexual education and counseling processes did not include pregnant women and their partners, and there were no studies evaluating the long-term effects on the sexual lives of couples. In this study, it was aimed to determine the effect of sexual education-counseling given to couples with sexual dysfunction in the preconceptional period in accordance with the PLISSIT model on their sexual functions during pregnancy and postpartum period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Behavioral: sexual education and counselingAfter the initial evaluation, pregnant women who will be included in the study group will be given an appointment for 1 week later, they will be asked to come with their partners and couples will be given sexual education and counseling in line with the PLISSIT model. After the initial evaluation, couples will be interviewed in the 1st, 2nd and 3rd trimesters, their sexuality since the previous evaluation according to the PLISSIT model, their problems, if any, will be discussed and short counseling will be given if necessary. In the first 4 weeks after delivery, couples in the study group will receive sexual education and counseling for the postpartum period in line with the PLISSIT model. They will be interviewed at the 3rd and 6th month after delivery and their postpartum sexuality and problems, if any, will be discussed and the sexual functions of the couples for the last 4 weeks will be evaluated. |
| Control Group | Other | Other: Routine clinical careRoutine clinical care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- For a pregnant woman;
- A woman who had just received the result of a pregnancy test and was referred to the family health center due to a positive pregnancy,
- Who wants the pregnancy to continue,
- In the first 6-8 gh. of gestation,
- FSFI cut-off value for pre/conceptional period with a total score ≤26.55,
Key exclusion criteria (9 listed)
- Not planning to continue the pregnancy / planning to terminate the pregnancy,
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 education and counselingAfter the initial evaluation, pregnant women who will be included in the study group will be given an appointment for 1 week later, they will be asked to come with their partners and couples will be given sexual education and counseling in line with the PLISSIT model. After the initial evaluation, couples will be interviewed in the 1st, 2nd and 3rd trimesters, their sexuality since the previous evaluation according to the PLISSIT model, their problems, if any, will be discussed and short counseling will be given if necessary. In the first 4 weeks after delivery, couples in the study group will receive sexual education and counseling for the postpartum period in line with the PLISSIT model. They will be interviewed at the 3rd and 6th month after delivery and their postpartum sexuality and problems, if any, will be discussed and the sexual functions of the couples for the last 4 weeks will be evaluated. | Behavioural | Participant Group |
| Routine clinical careControl Group | Other | Control Group |
Primary outcome
Female Sexual Function Index (FSFI)
Time frame: 15 Months
According to the Female Sexual Function Index (FSFI) cut-off value to be applied to each sampled pregnant woman at the first encounter, pregnant women with a total score ≤26.55, that is, pregnant women with sexual dysfunction, will be identified.
The International Erectile Function Evaluation Form (IIEF)
Time frame: 15 Months
The International Erectile Function Evaluation Form (IIEF) is evaluated in 5 categories in terms of erectile function. These are; severe erectile dysfunction (ED) score (6-10), moderate ED score (11-16), moderate-mild ED score (17-21), mild ED score (22-25), no ED (26-30) (Cappelleri et al., 1999). The scores that can be obtained as a result of IIEF evaluation are between 5-75. Cut-off value is not specified.
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 9 Jan 2025.
- 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 and counseling and Routine clinical care in people with Pregnancy and Postpartum Period, run by Izmir Katip Celebi 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 11 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 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 (FSFI) (time frame: 15 Months). 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 9 Jan 2025.