PregnancyNCT06862011
Evaluation of Sexual Health Counseling for Primiparous Pregnant Women Using PLISSIT Model and Motivational Interviewing
A study of Pregnancy and PLISSIT Model, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study is a simple randomized controlled intervention study to evaluate the effects of sexual counseling given to primiparous pregnant women using motivational interviewing on sexual self-efficacy, attitude towards sexuality and quality of sexual life. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, PLISSIT Model, Primiparity
- 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
- 15 Mar 2025to 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those over 19 years of age
- Those in their first pregnancy
- Those in their 8th-16th weeks of pregnancy
- Those who are sexually active
- Those who have a score of less than 26.55 on the Female Sexual Function Scale (FSFI)
Who cannot join
- Those who have given birth prematurely
- Those who have developed a pregnancy complication that prevents coitus at any stage of the study (placenta previa, preterm premature rupture of membranes)
- Those who do not comply with the study plan
- Those who have received any sexual counseling
- Those who have experienced a life crisis (death of partner, divorce, moving, etc.)
- Those who want to withdraw from the study at any stage of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Structured Sexual Health Counseling for Primiparous Pregnant Women Based on PLISSIT Model Supported by Motivational Interviewing
This study is a simple randomized controlled intervention study to evaluate the effects of sexual counseling given to primiparous pregnant women using motivational interviewing on sexual self-efficacy, attitude towards sexuality and quality of sexual life.
HO: There is no difference between the mean Sexual Function Scale score in the last evaluation of pregnant women in the intervention and control groups.
Read more
H0a: There is no difference between the mean Sexual Self-Efficacy Scale score in the last evaluation of pregnant women in the intervention and control groups.
H0b: There is no difference between the mean Attitude Towards Sexuality During Pregnancy Scale score in the last evaluation of pregnant women in the intervention and control groups.
H0c: There is no difference between the mean Sexual Life Quality Scale score in the last evaluation of pregnant women in the intervention and control groups.
Read the detailed description
Pregnancy is a natural process that involves hormonal, physical, and social changes, affecting a woman's mood, relationships, and sexual life. The first pregnancy is a significant transition period, during which women may experience various fears related to sexuality, such as fear of miscarriage, premature birth, harming the baby, or increased risk of infection. These concerns often lead to a decrease in sexual activity during pregnancy.
The PLISSIT Model is suggested as an effective approach for assessing sexual health during pregnancy. This model consists of four stages: permission for expressing thoughts and concerns about sexuality, providing limited information, offering specific suggestions, and referring to intensive therapy when necessary. Additionally, the motivational interviewing method can help pregnant individuals recognize conflicting emotions and make positive behavioral changes.
Research indicates that sexual knowledge impacts sexual function, and participation in educational programs can improve sexual health during pregnancy. However, studies also show that healthcare professionals often lack sufficient support in this area. Nurses play a crucial role in educating and counseling pregnant women to enhance their awareness of sexual health. The absence of sexual health recommendations in the Ministry of Health's prenatal care guidelines highlights a gap in this area. Improving sexual quality of life during pregnancy is essential for strengthening women's self-confidence and sense of adequacy.
In the study, the data collection tools used were the Inclusion Criteria Questionnaire (ICQ), Personal Information Form, Sexuality Diary, Female Sexual Function Index (FSFI), Sexual Self-Efficacy Scale (SSES), Attitudes Towards Sexuality During Pregnancy Scale (ATSPS), and Sexual Quality of Life Questionnaire-Female Version (SQOL-F).
- ICQ: A ten-item form assessing the eligibility criteria for pregnant participants. Women who scored below 26.55 on the FSFI and answered all questions as "yes" were included in the study.
- Personal Information Form: A 15-item form assessing the socio-demographic and obstetric characteristics of pregnant individuals.
- FSFI: A scale evaluating female sexual function. A score below 26.55 indicates female sexual dysfunction.
- SSES: A scale measuring individuals' sexual self-efficacy, ranging from 0 to 40. Higher scores indicate higher sexual self-efficacy.
- ATSPS: A 34-item Likert-type scale assessing attitudes toward sexuality during pregnancy. Higher scores indicate a more positive attitude. The cutoff point is set at 111.5.
- Conditions
- Pregnancy, PLISSIT Model, Primiparity
- Being tested
- control group
- Keywords
- pregnancy, primiparous, PLISSIT, Sexual counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupBehavioural
Only surveys will be filled out.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (pregnant women receiving sexual counselling) | Experimental | In the intervention phase of the study, sexual counseling based on the PLISSIT model supported by motivational interviewing will be provided. The average duration of each counseling session is planned to be 60 minutes. Receives: Behavioral: control group |
| Control Group (pregnant women not receiving sexual counselling) | No intervention | Scales and forms for the control group will be completed at the end of the second and fourth weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Scale
The Female Sexual Function Scale will be used to evaluate the sexual functions of pregnant women. The total score that can be obtained from the scale is between a minimum of 2 and a maximum of 36 points. Increasing scores indicate a good level of sexual function. If the total KCFI score is 30 and above, the sexual function level is defined as "good", between 23-29 points as "medium", and less than 23 points as low, and the cut-off value of the scale is 26.55. A total KCFI score of 26.55 and below indicates that the level of sexual function is inadequate.
Measured: 5 weeks
Secondary outcomes (1)
Sexual Self-Efficacy Scale
will be used to determine the sexual self-efficacy levels of pregnant women. The scale is one-dimensional. The lowest score that can be obtained from the scale is 0, the highest score is 40. High scores indicate a high level of sexual self-sufficiency belief.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 Mar 2025
- Primary completion15 May 2025 (estimated)
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Özlem SEYMEN, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862011
- Sponsor's protocol ID
- GaziosmanpasaU-OS
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Supporting information: CSR
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Structured Sexual Health Counseling for Primiparous Pregnant Women Based on PLISSIT Model Supported by Motivational Interviewing
- ClinicalTrials.gov ID
- NCT06862011
- Acronym / sponsor ID
- GaziosmanpasaU-OS
- Conditions
- Pregnancy, PLISSIT Model, Primiparity
- Keywords
- pregnancy, primiparous, PLISSIT, Sexual counseling
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Mar 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.
This study is a simple randomized controlled intervention study to evaluate the effects of sexual counseling given to primiparous pregnant women using motivational interviewing on sexual self-efficacy, attitude towards sexuality and quality of sexual life.
HO: There is no difference between the mean Sexual Function Scale score in the last evaluation of pregnant women in the intervention and control groups.
H0a: There is no difference between the mean Sexual Self-Efficacy Scale score in the last evaluation of pregnant women in the intervention and control groups.
H0b: There is no difference between the mean Attitude Towards Sexuality During Pregnancy Scale score in the last evaluation of pregnant women in the intervention and control groups.
H0c: There is no difference between the mean Sexual Life Quality Scale score in the last evaluation of pregnant women in the intervention and control groups.
Detailed description
Pregnancy is a natural process that involves hormonal, physical, and social changes, affecting a woman's mood, relationships, and sexual life. The first pregnancy is a significant transition period, during which women may experience various fears related to sexuality, such as fear of miscarriage, premature birth, harming the baby, or increased risk of infection. These concerns often lead to a decrease in sexual activity during pregnancy.
The PLISSIT Model is suggested as an effective approach for assessing sexual health during pregnancy. This model consists of four stages: permission for expressing thoughts and concerns about sexuality, providing limited information, offering specific suggestions, and referring to intensive therapy when necessary. Additionally, the motivational interviewing method can help pregnant individuals recognize conflicting emotions and make positive behavioral changes.
Research indicates that sexual knowledge impacts sexual function, and participation in educational programs can improve sexual health during pregnancy. However, studies also show that healthcare professionals often lack sufficient support in this area. Nurses play a crucial role in educating and counseling pregnant women to enhance their awareness of sexual health. The absence of sexual health recommendations in the Ministry of Health's prenatal care guidelines highlights a gap in this area. Improving sexual quality of life during pregnancy is essential for strengthening women's self-confidence and sense of adequacy.
In the study, the data collection tools used were the Inclusion Criteria Questionnaire (ICQ), Personal Information Form, Sexuality Diary, Female Sexual Function Index (FSFI), Sexual Self-Efficacy Scale (SSES), Attitudes Towards Sexuality During Pregnancy Scale (ATSPS), and Sexual Quality of Life Questionnaire-Female Version (SQOL-F).
- ICQ: A ten-item form assessing the eligibility criteria for pregnant participants. Women who scored below 26.55 on the FSFI and answered all questions as "yes" were included in the study.
- Personal Information Form: A 15-item form assessing the socio-demographic and obstetric characteristics of pregnant individuals.
- FSFI: A scale evaluating female sexual function. A score below 26.55 indicates female sexual dysfunction.
- SSES: A scale measuring individuals' sexual self-efficacy, ranging from 0 to 40. Higher scores indicate higher sexual self-efficacy.
- ATSPS: A 34-item Likert-type scale assessing attitudes toward sexuality during pregnancy. Higher scores indicate a more positive attitude. The cutoff point is set at 111.5.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Intervention group (pregnant women receiving sexual counselling) | Experimental | Behavioral: control groupIn the intervention phase of the study, sexual counseling based on the PLISSIT model supported by motivational interviewing will be provided. The average duration of each counseling session is planned to be 60 minutes. |
| Control Group (pregnant women not receiving sexual counselling) | No intervention | –Scales and forms for the control group will be completed at the end of the second and fourth weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Those over 19 years of age
- Those in their first pregnancy
- Those in their 8th-16th weeks of pregnancy
- Those who are sexually active
- Those who have a score of less than 26.55 on the Female Sexual Function Scale (FSFI)
Key exclusion criteria (6 listed)
- Those who have given birth prematurely
- Those who have developed a pregnancy complication that prevents coitus at any stage of the study (placenta previa, preterm premature rupture of membranes)
- Those who do not comply with the study plan
- Those who have received any sexual counseling
- Those who have experienced a life crisis (death of partner, divorce, moving, 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 |
|---|---|---|
| control groupOnly surveys will be filled out. | Behavioural | Intervention group (pregnant women receiving sexual counselling) |
Primary outcome
Female Sexual Function Scale
Time frame: 5 weeks
The Female Sexual Function Scale will be used to evaluate the sexual functions of pregnant women. The total score that can be obtained from the scale is between a minimum of 2 and a maximum of 36 points. Increasing scores indicate a good level of sexual function. If the total KCFI score is 30 and above, the sexual function level is defined as "good", between 23-29 points as "medium", and less than 23 points as low, and the cut-off value of the scale is 26.55. A total KCFI score of 26.55 and below indicates that the level of sexual function is inadequate.
1 secondary outcome
Sexual Self-Efficacy Scale
Time frame: 5 weeks
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 25 Apr 2025.
- Individual participant dataSharing planned: Yes. Supporting information: CSR
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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 of Pregnancy and PLISSIT Model, run by Tokat Gaziosmanpasa 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 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Apr 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 Scale (time frame: 5 weeks). 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 25 Apr 2025.