SexualityNCT07517549
Sexual Health Education During Pregnancy
A study testing sexuality health education group in people with Sexuality and Depression, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This experimental, randomized controlled, single-blind study includes intervention and control groups. Pregnant women between 16 and 20 weeks of gestation who meet the inclusion criteria and agree to participate will be included in the study. Pregnant women will be randomly assigned to groups. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexuality, Depression, Pregnancy Related
- What is being tested?
- sexuality health education group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 30 Nov 2026
- Phase
- Interventional
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Someone who has been diagnosed with a chronic illness,
- People with diagnosed physical and mental health issues,
- Someone who has been diagnosed with a psychological disorder,
- Having a high-risk pregnancy,
- Having an IVF pregnancy,
- Low threat,
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- Anyone who has been diagnosed with any sexually transmitted disease, either themselves or in their partner,
- Those using medications that may negatively affect sexual function,
- including antipsychotics, antihypertensives, phenobarbital, and opioids.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ordu University
Altinordu, Ordu, 52200
Gizem YILDIZ, MSc., 05442390166, gizemg.2795@gmail.com
gizemyildiz@odu.edu.tr
About this study
Official title: The Effect Of Sexual Counseling Based On the Extended Plissit Model On Sexual Function, Marital Adjustment, Sexual Quality Of Life, Depression, Anxiety, And Stress During Pregnancy And Postpartum
This experimental, randomized controlled, single-blind study includes intervention and control groups. Pregnant women between 16 and 20 weeks of gestation who meet the inclusion criteria and agree to participate will be included in the study. Pregnant women will be randomly assigned to groups. Pre-test data will be collected from both groups. The intervention group will receive sexual counseling training in two sessions, face-to-face and in groups, until week 22. Second test data will be collected after week 37 (before delivery), and final test data will be collected three months after delivery. This study is expected to have a significant impact on women's lives, as this topic is considered taboo in our country, leading to a lack of open discussion and the prevalence of misconceptions and false beliefs (sexual myths).
Read the detailed description
While it varies from woman to woman, there is generally a decrease in the frequency of sexual intercourse in the first trimester due to decreased libido, and avoidance of sexual intercourse is quite common in the first three months due to the belief that it is associated with a risk of miscarriage. The belief that partners may harm the fetus during sexual intercourse is another important factor that negatively affects men's sexual desire and arousal and reduces the quality of sexual intercourse. Conversely, the results of some studies suggest that sexual intercourse is most comfortable in the first trimester. In their study with pregnant women, Khalesi et al. (2018) reported that pregnant women's interest in sexuality decreased in the first trimester, increased in the second trimester, and decreased again in the third trimester. In the same study, it was found that the frequency of sexual activity reached lower levels in the early stages of pregnancy and in the third trimester, and it was reported that 90% of pregnant women did not have sexual intercourse in the last four weeks of pregnancy. During pregnancy, a decrease in sexual intercourse and a lack of interest in sexuality are the most common occurrences. Studies have shown that the decrease in the frequency of sexual intercourse and sexual desire during pregnancy varies between 40% and 100%.
Pregnant women whose sexual life quality is negatively affected also experience negative impacts on their marital harmony. Maintaining a healthy and happy sexual life is crucial for the continuation of a marriage. Deterioration in sexual life and marital harmony during pregnancy continues to cause problems between couples in the postpartum period. With childbirth, estrogen decreases, while oxytocin and prolactin hormones increase. The effect of increased prolactin on the decrease in androgen hormones leads to decreased sexual desire and arousal. In the postpartum period, decreased estrogen causes problems such as decreased vaginal lubrication, dryness, and decreased vaginal congestion, leading to dyspareunia and decreased/avoidant sexual desire; decreased sexual desire is the most common problem in the postpartum period. In our culture, during the period called postpartum, women try to adapt to their new lives, and avoiding sexual intercourse is common due to the risk of postpartum bleeding and infection related to episiotomy. Additionally, mothers face many challenges during the postpartum period, trying to adjust to their new lives. Fatigue, insomnia, and difficulties with breastfeeding increase susceptibility to symptoms such as depression, anxiety, and stress. These mental health issues can lead to communication problems, withdrawal, and estrangement from their spouses. These problems negatively impact the marital harmony of the couple. Mental health issues can also lead to decreased sexual activity, and antidepressant medications used during treatment can cause orgasm problems. Sexual myths are also one of the reasons why sexual life is negatively affected during pregnancy . Misinformation believed to be true causes pregnant women to distance themselves from sexuality. Breastfeeding also has an impact on sexual life during the postpartum period. Problems such as milk leakage from the breasts during intercourse, the mother feeling unattractive, breast tenderness due to enlargement, and cracked nipples also negatively affect sexual intercourse . One study reported that breastfeeding women experienced more dyspareunia than non-breastfeeding women, and that non-breastfeeding women had greater sexual satisfaction . Various studies on the time required for sexual life to return to normal in the postpartum period are available in the literature. One study found that breastfeeding women experienced more sexual dysfunction in the first 4 months after childbirth .
Sexual counseling education plays a crucial role in resolving issues related to sexual life that arise during pregnancy and the postpartum period. In our country, routine sexual counseling education during pregnancy and the postpartum period is insufficient. Since sexuality is often overlooked in our country, it is essential to provide couples with sexual counseling education starting from pregnancy and to continue monitoring them in the postpartum period, including an assessment of their sexual life quality.
Several models have been developed for providing sexual counseling education.
- Conditions
- Sexuality, Depression, Pregnancy Related
- Being tested
- sexuality health education group
- Keywords
- Sexuality, Pregnancy, Anxiety
- Medical subject headings
- Sexuality, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexuality health education groupOther
This study will provide sexual counseling to pregnant women. Results will be collected both before delivery and at 3 months postpartum. The difference is that it covers both the pregnancy and postpartum periods.
| Study group | Role | What they receive |
|---|---|---|
| sexual health education groups | Active comparator | sexual health education groups Receives: Other: sexuality health education group |
| routine care groups | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Scale
The scale consists of 6 sub-dimensions and 19 items: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. The scale evaluates sexual function status based on problems experienced over the past four weeks. Questions 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 13, 14, 17, 18, and 19 use a six-point Likert scale (0-5 points).The cutoff score for the scale is 26.55; a score ≤26.55 is considered to indicate a negative change in sexual function.A higher score indicates good sexual function.
Measured: 20.pregnancy week until postpartum third month
Depression Anxiety Stress-21 Scale
In the scoring of the scale a score range of (0-4) indicates normal level of depression, a score range of (0-3) indicates normal level of anxiety, and a score range of (0-7) indicates normal level of stress. depression min 0-max 14, anxiety min 0- max 10, stres min 0- max 17. A higher score indicates increased levels of depression, anxiety, and stress.
Measured: 22. pregnancy week until postpartum third month
Sexual Life Quality Scale - Women
Each item on the scale is scored between 1 and 6. The scale items are scored as follows: "Strongly agree"=1, "Largely agree"=2, "Partially agree"=3, "Partially disagree"=4, "Largely disagree"=5, "Strongly disagree"=6. The possible score range from 18 to 108. Min 18-max 108 score.A higher score indicates good sexual function.
Measured: 22.pregnancy week - postpartum third month
Marital Adjustment Scale
The Marital Adjustment Scale consists of 15 items and three sections. Items in the scale receive a score between 0 and 6 depending on the number of options chosen. A higher score indicates good marital harmony.
Measured: 22. pregnancy week until postpartum third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start15 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for SexualityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This experimental, randomized controlled, single-blind study includes intervention and control groups. Pregnant women between 16 and 20 weeks of gestation who meet the inclusion criteria and agree to participate will be included in the study. Pregnant women will be randomly assigned to groups. Pre-test data will be collected from both groups. The intervention group will receive sexual counseling training in two sessions, face-to-face and in groups, until week 22. Second test data will be collected after week 37 (before delivery), and final test data will be collected three months after delivery. This study is expected to have a significant impact on women's lives, as this topic is considered taboo in our country, leading to a lack of open discussion and the prevalence of misconceptions and false beliefs (sexual myths).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Yıldız, Ordu University
- Investigators
- Gizem YILDIZ, MSc, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517549
- Sponsor's protocol ID
- Ordu U
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelhakm, E. M., Said, A. R., & Elsayed, D. M. S. (2018). Effect of PLISSIT model sexual counseling program on sexual quality of life for postpartum women. American Journal of Nursing Science, 7(2), 63-72
Akyuz MD, Turfan EC, Oner SC, Sakar T, Aktay DM. Sexual functions in pregnancy: different situations in near geography:a case study on Turkey, Iran and Greece. J Matern Fetal Neonatal Med. 2020 Jan;33(2):222-229. doi: 10.1080/14767058.2018.1488164. Epub 2018 Sep 9.
PubMed 29890872Altunbaş, N. (2021). Zehra Gölbaşı. The effect of a sexual education and counseling program developed according to the Ex-PLISSIT model for pregnant women on their sexual life [Doctoral dissertation, Sivas Cumhuriyet University Institute of Health Sciences].
Annon, J. (1976). The PLISSIT model: A proposed conceptual scheme for the behavioural treatment of sexual problems. Journal of Sex Education and Therapy, 2(1), 1-15. https://doi.org/10.1080/01614576.1976.11074483
Aygin, D., & Aslan, F. E. (2005). Adaptation of the Female Sexual Function Scale into Turkish. Türkiye Klinikleri, 25(3), 393-399
Beyazıt, F., Pek, E., & Şahin, B. (2018). Changes in sexual function observed during pregnancy and postpartum: Prejudice or reality? Clinical Psychiatry, 21, 397-406.
Bilgi, K., & Bilge, Ç. (2021). The invisible face of the postpartum period: Sexual dysfunction. Karya Journal of Health Science, 2(3), 88-92. https://doi.org/10.52831/kjhs.845668
Cicek Ozdemir S, Dogan Gangal A, Senturk Erenel A. The Effect of Sexual Counseling Based on PLISSIT and EX-PLISSIT Models on Sexual Function, Satisfaction, and Quality of Life: A Systematic Review and Meta-Analysis. Arch Sex Behav. 2024 Oct;53(9):3485-3513. doi: 10.1007/s10508-024-02898-2. Epub 2024 Jun 18.
PubMed 38890226Corbacioglu Esmer A, Akca A, Akbayir O, Goksedef BP, Bakir VL. Female sexual function and associated factors during pregnancy. J Obstet Gynaecol Res. 2013 Jun;39(6):1165-72. doi: 10.1111/jog.12048. Epub 2013 May 30.
PubMed 23718891Dabiri F, Yabandeh AP, Shahi A, Kamjoo A, Teshnizi SH. The effect of mode of delivery on postpartum sexual functioning in primiparous women. Oman Med J. 2014 Jul;29(4):276-9. doi: 10.5001/omj.2014.72.
PubMed 25170409Guendler, J., Katz, L., Flamini, M. E., Lemos, A., & Amorim, M. (2019). Prevalence of sexual dysfunctions and orientations on sexuality in postpartum women: Cross-sectional study. Obstetrics & Gynecology, 133(1), 213-214. Doi: 10.1097/01.AOG.0000559105.67034.96
Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.
PubMed 40228833Karimi, F., Babazadeh, R., Asgharipour, N., Esmaily, H., & Roudsari, R. L. (2019). The effectiveness of counseling using PLISSIT model on depression, anxiety and stress among postpartum women with sexual dysfunction: A randomized trial. Journal of Midwifery & Reproductive Health, 7(4),1912-1920. DOI: 10.22038/jmrh.2019.36434.1399
Karimi F, Babazadeh R, Roudsari RL, Asgharipour N, Esmaily H. Comparing the Effectiveness of Sexual Counseling Based on PLISSITand BETTER Models on Sexual Selfdisclosure in Women with Sexual Problems after Childbirth: A Randomized Trial. Iran J Nurs Midwifery Res. 2021 Jan 18;26(1):68-74. doi: 10.4103/ijnmr.IJNMR_265_19. eCollection 2021 Jan-Feb.
PubMed 33954101Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811