Sexual Health Education During Pregnancy

NCT07517549 | Recruiting

• 1 other identifier: Ordu U
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sexuality; Depression; Pregnancy Related

Keywords

Sexuality; Pregnancy; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  22. pregnancy week until postpartum third month

Study Arms (2)

sexual health education groups

ACTIVE COMPARATOR

sexual health education groups

Other: sexuality health education group

routine care groups

NO INTERVENTION

routine care

Interventions

sexuality health education group OTHER

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.

sexual health education groups

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Altinordu, Ordu, 52200, Turkey (Türkiye)

RECRUITING

Related Publications (36)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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].

  BACKGROUND

• 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

  BACKGROUND

• Aygin, D., & Aslan, F. E. (2005). Adaptation of the Female Sexual Function Scale into Turkish. Türkiye Klinikleri, 25(3), 393-399

  BACKGROUND

• Beyazıt, F., Pek, E., & Şahin, B. (2018). Changes in sexual function observed during pregnancy and postpartum: Prejudice or reality? Clinical Psychiatry, 21, 397-406.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Lovibond, P. F., & Lovibond, S. H. (1995). Depression anxiety and stress scales. Behaviour Research and Therapy. https://doi.org/10.1037/t39835-000

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Büyüköztürk, Ş. (2014). Data analysis handbook for social sciences (20th edition). Pegem Academy Publications

  BACKGROUND

• 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

  BACKGROUND

• Taylor, B., & Davis, S. (2006). Using the extended PLISSIT model to address sexual healthcare needs. Nursing Standard, 21(11), 35-40

  BACKGROUND

• 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

  BACKGROUND

• Tutarel-Kışlak, Ş. (1999). Reliability and validity study of the Marital Adjustment Scale (MAS). 3P (Psychiatry Psychology Psychopharmacology) Journal, 7(1), 50-57.

  BACKGROUND

• Tuğut, N., & Gölbaşı, Z. (2013). Use of PLISSIT model in the evaluation of sexuality. Gümüşhane University Journal of Health Sciences, 2(4), 526-531

  BACKGROUND

• 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.

  BACKGROUND

• Uçtu, A. K., Bekmezci, N., & Özerdoğan, N. (2017). Sexuality during pregnancy. Gümüşhane University Journal of Health Sciences, 6(3), 171-175.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Sexuality; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Gizem YILDIZ, MSc

  Ordu University

  STUDY DIRECTOR

Central Study Contacts

Gizem YILDIZ, MSc

CONTACT

+905442390166; gizemg.2795@gmail.com

Gizem YILDIZ, MSc

CONTACT

05442390166; gizemg.2795@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Model Details: 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).

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 8, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)