ClinicalTrials.gg
RecruitingNCT07517549Updated Apr 8, 2026

Sexual Health Education During Pregnancy

An interventional study of sexuality health education group in Sexuality, Depression and Pregnancy Related, sponsored by Ordu University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Ordu University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Sexuality
  • Depression
  • Pregnancy Related

Keywords

  • Sexuality
  • Pregnancy
  • Anxiety
03

In context

Sexuality

130 studies on the registry are indexed under Sexuality; 26 are open to participants now.

This study's planned enrollment of 70 is close to the median of 75 across 79 interventional studies indexed under Sexuality.

Browse Sexuality studies →

Lead sponsor

Ordu University is the lead sponsor of 32 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Eligibility criteria;

  • Volunteers to participate in the research,
  • primary school graduate,
  • Pregnant between 16-20 weeks
  • Having a single pregnancy,
  • Able to understand and speak Turkish,
  • Living with his wife for the past four weeks,
  • No threat of abortion or premature birth,

Exclusion Criteria:

  • 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,
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    sexual health education groups

    sexual health education groups

    Other: sexuality health education group

  • No intervention
    routine care groups

    routine care

Interventions

  • Othersexuality health education group

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20.pregnancy week until postpartum third month

  2. 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.

    Time frame: 22. pregnancy week until postpartum third month

  3. 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.

    Time frame: 22.pregnancy week - postpartum third month

  4. 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.

    Time frame: 22. pregnancy week until postpartum third month

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 29890872 ↗
  • Altunbaş, 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 38890226 ↗
  • Corbacioglu 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 23718891 ↗
  • Dabiri 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 25170409 ↗
  • Guendler, 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 40228833 ↗
  • Karimi, 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 33954101 ↗
  • Lovibond 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 ↗
  • Khalesi ZB, Bokaie M, Attari SM. Effect of pregnancy on sexual function of couples. Afr Health Sci. 2018 Jun;18(2):227-234. doi: 10.4314/ahs.v18i2.5. PubMed 30602947 ↗
  • Locke, H. J., & Wallace, K. M. (1959). Short marital-adjustment and prediction tests: Their reliability and validity, Marriage and Family Living, 21(3), 251-255. https://doi.org/10.2307/348022
  • Malakouti J, Golizadeh R, Mirghafourvand M, Farshbaf-Khalili A. The effect of counseling based on ex-PLISSIT model on sexual function and marital satisfaction of postpartum women: A randomized controlled clinical trial. J Educ Health Promot. 2020 Oct 30;9:284. doi: 10.4103/jehp.jehp_168_20. eCollection 2020. PubMed 33282989 ↗
  • Matthies LM, Wallwiener M, Sohn C, Reck C, Muller M, Wallwiener S. The influence of partnership quality and breastfeeding on postpartum female sexual function. Arch Gynecol Obstet. 2019 Jan;299(1):69-77. doi: 10.1007/s00404-018-4925-z. Epub 2018 Oct 16. PubMed 30327862 ↗
  • Perz J, Ussher JM; Australian Cancer and Sexuality Study Team. A randomized trial of a minimal intervention for sexual concerns after cancer: a comparison of self-help and professionally delivered modalities. BMC Cancer. 2015 Sep 9;15:629. doi: 10.1186/s12885-015-1638-6. PubMed 26353787 ↗
  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597. PubMed 10782451 ↗
  • Rosen NO, Mooney K, Muise A. Dyadic Empathy Predicts Sexual and Relationship Well-Being in Couples Transitioning to Parenthood. J Sex Marital Ther. 2017 Aug 18;43(6):543-559. doi: 10.1080/0092623X.2016.1208698. Epub 2016 Jul 11. PubMed 27400021 ↗
  • Sariçam, H. (2018). The psychometric properties of Turkish version of Depression Anxiety Stress Scale-21 (DASS-21) in health control and clinical samples. Journal of Cognitive Behavioral Psychotherapies and Research, 7(1), 19-30. DOI: 10.5455/JCBPR.274847
  • Shirvani MA, Nesami MB, Bavand M. Maternal sexuality after child birth among Iranian women. Pak J Biol Sci. 2010 Apr 15;13(8):385-9. doi: 10.3923/pjbs.2010.385.389. PubMed 20836299 ↗
  • Sundstrom Poromaa I, Comasco E, Georgakis MK, Skalkidou A. Sex differences in depression during pregnancy and the postpartum period. J Neurosci Res. 2017 Jan 2;95(1-2):719-730. doi: 10.1002/jnr.23859. PubMed 27870443 ↗
  • Büyüköztürk, Ş. (2014). Data analysis handbook for social sciences (20th edition). Pegem Academy Publications
  • Symonds T, Boolell M, Quirk F. Development of a questionnaire on sexual quality of life in women. J Sex Marital Ther. 2005 Oct-Dec;31(5):385-97. doi: 10.1080/00926230591006502. PubMed 16169822 ↗
  • Taylor B, Davis S. Using the extended PLISSIT model to address sexual healthcare needs. Nurs Stand. 2006 Nov 22-28;21(11):35-40. doi: 10.7748/ns2006.11.21.11.35.c6382. PubMed 17165482 ↗
  • Taylor, B., & Davis, S. (2007). The extended PLISSIT model for addressing the sexual well-being of individuals with an acquired disability or chronic illness. Sexuality and Disability, 25, 135-139. https://doi.org/10.1007/s11195-007-9044-x
  • Tutarel-Kışlak, Ş. (1999). Reliability and validity study of the Marital Adjustment Scale (MAS). 3P (Psychiatry Psychology Psychopharmacology) Journal, 7(1), 50-57.
  • Tuğut, N., & Gölbaşı, Z. (2013). Use of PLISSIT model in the evaluation of sexuality. Gümüşhane University Journal of Health Sciences, 2(4), 526-531
  • Tuğut, N., & Gölbaşı, Z. (2010). Validity and reliability study of the Turkish version of the Sexual Life Quality Scale - Female. Cumhuriyet Medical Journal, 32, 172-180.
  • Uçtu, A. K., Bekmezci, N., & Özerdoğan, N. (2017). Sexuality during pregnancy. Gümüşhane University Journal of Health Sciences, 6(3), 171-175.
  • Yildiz H. The relation between prepregnancy sexuality and sexual function during pregnancy and the postpartum period: a prospective study. J Sex Marital Ther. 2015;41(1):49-59. doi: 10.1080/0092623X.2013.811452. Epub 2013 Dec 13. PubMed 24328753 ↗
  • Alp Yilmaz F, Sener Taplak A, Polat S. Breastfeeding and Sexual Activity and Sexual Quality in Postpartum Women. Breastfeed Med. 2019 Oct;14(8):587-591. doi: 10.1089/bfm.2018.0249. Epub 2019 Jul 12. PubMed 31298557 ↗
  • Ziaei T, Keramat A, Kharaghani R, Haseli A, Ahmadnia E. Comparing the Effect of Extended PLISSIT Model and Group Counseling on Sexual Function and Satisfaction of Pregnant Women: A Randomized Clinical Trial. J Caring Sci. 2022 Jan 10;11(1):7-14. doi: 10.34172/jcs.2022.06. eCollection 2022 Mar. PubMed 35603090 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Nov 2026, 8 months after the start.

Of 54 non-industry interventional studies with no phase under Sexuality, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 32. This study's planned 8 months is below that.

Counting every sponsor, half of 54 studies reached it within 12 months; a quarter within 6 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2026
First posted
Apr 8, 2026
StartActual
Mar 15, 2026
Primary completionEst.
Nov 30, 2026
CompletionEst.
Nov 30, 2026
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07517549
Lead sponsor
Ordu University
Responsible party
Gizem Yıldız (Research Asistant, Ordu University) — Principal investigator
First posted
Apr 8, 2026
Start date
Mar 15, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Apr 8, 2026

Study contacts

Gizem YILDIZ, MSc
Contact
gizemg.2795@gmail.com
+905442390166
Gizem YILDIZ, MSc
Contact
gizemg.2795@gmail.com
05442390166
Gizem YILDIZ, MSc
study director · Ordu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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