- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517549
Sexual Health Education During Pregnancy
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gizem YILDIZ, MSc
- Phone Number: +905442390166
- Email: gizemg.2795@gmail.com
Study Contact Backup
- Name: Gizem YILDIZ, MSc
- Phone Number: 05442390166
- Email: gizemg.2795@gmail.com
Study Locations
-
-
Ordu
-
Altinordu, Ordu, Turkey (Türkiye), 52200
- Recruiting
- Ordu University
-
Contact:
- Gizem YILDIZ, MSc.
- Phone Number: 05442390166
- Email: gizemg.2795@gmail.com
-
Contact:
- Email: gizemyildiz@odu.edu.tr
-
Principal Investigator:
- Nülüfer ERBİL, Prof.Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: sexual health education groups
|
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.
|
|
No Intervention: routine care groups
routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female Sexual Function Scale
Time Frame: 20.pregnancy week until postpartum third month
|
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.
|
20.pregnancy week until postpartum third month
|
|
Depression Anxiety Stress-21 Scale
Time Frame: 22. pregnancy week until postpartum third month
|
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.
|
22. pregnancy week until postpartum third month
|
|
Sexual Life Quality Scale - Women
Time Frame: 22.pregnancy week - postpartum third month
|
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.
|
22.pregnancy week - postpartum third month
|
|
Marital Adjustment Scale
Time Frame: 22. pregnancy week until postpartum third month
|
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.
|
22. pregnancy week until postpartum third month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gizem YILDIZ, MSc, Ordu University
Publications and helpful links
General 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, M. D., Turfan, E. C., Oner, S. C., Sakar, T., & Aktay, D. M. (2018). Sexual functions in pregnancy: Different situations in near geography: A case study on Turkey, Iran and Greece. Journal of Maternal-Fetal & Neonatal Medicine, 9, 1-8. https://doi.org/10.1080/14767058.2018.1488164
- 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. (2024). 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. Archives of Sexual Behavior, 53(9), 3485-3513. https://doi.org/10.1007/s10508-024-02898-2
- Çorbacıoğlu, E. A., Akça, A., Akbayır, O., Göksedef, B. P., & Bakır, V. L. (2013). Female sexual function and associated factors during pregnancy. Journal of Obstetrics and Gynaecology Research, 39(6), 1165-1172. https://doi.org/10.1111/jog.12048
- Dabiri, F., Yabandeh, A. P., Shahi, A., Kamjoo, A., & Teshnizi, S. H. (2014). The effect of mode of delivery on postpartum sexual functioning in primigravidous women. Oman Medical Journal, 29(4), 276-279. doi: 10.5001/omj.2014.72
- 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., Hróbjartsson, A., Moher, D., & Schulz, KF, et al. (2025). CONSORT 2025 Statement: updated guideline for reporting randomised trials. BMJ. 388:e081123. https://dx.doi.org/10.1136/bmj-2024-081123
- 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, R. L., Asgharipour, N., & Esmaily, H. (2021). Comparing the effectiveness of sexual counseling based on PLISSIT and BETTER models on sexual self-disclosure in women with sexual problems after childbirth: A randomized trial. Iranian Journal of Nursing and Midwifery Research, 26(1), 68-74. Doi: 10.4103/ijnmr.IJNMR_265_19
- Lovibond, P. F., & Lovibond, S. H. (1995). Depression anxiety and stress scales. Behaviour Research and Therapy. https://doi.org/10.1037/t39835-000
- Khalesi, Z. B., Bokaie, M., & Attari, S. M. (2018). Effect of pregnancy on sexual function of couples. African Health Sciences, 18(2), 227-234. 10.4314/ahs.v18i2.5
- 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. (2020). The effect of counseling based on EX-PLISSIT model on sexual function and marital satisfaction of postpartum women: A randomized controlled clinical trial. Journal of Education and Health Promotion, 9(1), 284-290. Doi: 10.4103/jehp.jehp_168_20
- Matthies, L. M., Wallwiener, M., Sohn, C., Reck, C., Müller, M., & Wallwiener, S. (2019). The influence of partnership quality and breastfeeding on postpartum female sexual function. Archives of Gynecology and Obstetrics, 299(1), 69-77. https://doi.org/10.1007/s00404-018-4925-z
- Perz, J., Ussher, J. M., & Australian Cancer and Sexuality Study Team. (2015). A randomized trial of a minimal intervention for sexual concerns after cancer: A comparison of self-help and professionally delivered modalities. BMC Cancer, 15(629), 1-16. https://doi.org/10.1186/s12885-015-1638-6
- Rosen, C., Brown, J., Heiman, S., Leiblum, C., Meston, R., Shabsigh, D., Ferguson, R., & D'Agostino, R. (2000). The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. Journal of Sex and Marital Therapy, 26(2), 191-208. https://doi.org/10.1080/009262300278597
- Rosen, N. O., Mooney, K., & Muise, A. (2017). Dyadic empathy predicts sexual and relationship well-being in couples transitioning to parenthood. Journal of Sex & Marital Therapy, 43(6), 543-559. https://doi.org/10.1080/0092623X.2016.1208698
- 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, M. A., Nesami, M. B., & Bavand, M. (2010). Maternal sexuality after childbirth among Iranian women. Pakistan Journal of Biological Sciences, 13(8), 385-389. https://doi.org/10.3923/pjbs.2010.385.389
- Sundström Poromaa, I., Comasco, E., Georgakis, M. K., & Skalkidou, A. (2017). Sex differences in depression during pregnancy and the postpartum period. Journal of Neuroscience Research, 95(1-2), 719-730. https://doi.org/10.1002/jnr.23859
- Büyüköztürk, Ş. (2014). Data analysis handbook for social sciences (20th edition). Pegem Academy Publications
- Symonds, T., Boolell, M., & Quirk, F. (2005). Development of a questionnaire on sexual quality of life in women. Journal of Sex & Marital Therapy, 31(5), 385-397. https://doi.org/10.1080/00926230591006502
- Taylor, B., & Davis, S. (2006). Using the extended PLISSIT model to address sexual healthcare needs. Nursing Standard, 21(11), 35-40
- 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.
- Yıldız, H. (2015). The relation between prepregnancy sexuality and sexual function during pregnancy and the postpartum period: A prospective study. Journal of Sex & Marital Therapy, 41(1), 49-59. https://doi.org/10.1080/0092623X.2013.811452
- Yılmaz, F., Şener Taplak, A., & Polat, S. (2019). Breastfeeding and sexual activity and sexual quality in postpartum women. Breastfeeding Medicine, 14(8), 587-591. https://doi.org/10.1089/bfm.2018.0249
- Ziaei, T., Keramat, A., Kharaghani, R., Haseli, A., & Ahmadnia, E. (2022). Comparing the effect of extended PLISSIT model and group counseling on sexual function and satisfaction of pregnant women: A randomized clinical trial. Journal of Caring Sciences, 11(1), 7-14. doi: 10.34172/jcs.2022.06
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ordu U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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