Evaluation of Sexual Health Counseling for Primiparous Pregnant Women Using PLISSIT Model and Mot… (NCT06862011) | Clinical Trial Compass
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Evaluation of Sexual Health Counseling for Primiparous Pregnant Women Using PLISSIT Model and Motivational Interviewing
Turkey (Türkiye)70 participantsStarted 2025-03-15
Plain-language 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.
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.
Who can participate
Age range
19 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.