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Recruiting NCT07517549

Sexual Health Education During Pregnancy

No phase Interventional Sexuality Depression Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sexuality health education group.
Who it may be relevant to
Registry conditions: Sexuality, Depression, Pregnancy Related. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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).

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.

Interventions

  • Other sexuality 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.

Primary outcome measures

  • Female Sexual Function Scale [Time frame: 20.pregnancy week until postpartum third month]
  • Depression Anxiety Stress-21 Scale [Time frame: 22. pregnancy week until postpartum third month]
  • Sexual Life Quality Scale - Women [Time frame: 22.pregnancy week - postpartum third month]
  • Marital Adjustment Scale [Time frame: 22. pregnancy week until postpartum third month]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Ordu University — Altinordu

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. PMID 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. PMID 38890226

Identifiers

NCT: NCT07517549 · Ordu U

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗