Utilizing Electronic Modules to Educate on Sexual Health Practices During Pregnancy

Обзор

This study looks at whether an interactive online education module can improve knowledge, comfort, and communication about sexual health during pregnancy. Many pregnant individuals experience changes in sexual function and intimacy but may feel uncomfortable discussing these topics or may have misconceptions about what is safe during pregnancy. Participants who are pregnant and receiving routine prenatal care will be randomly assigned to one of two groups. One group will complete an interactive, evidence-based educational module focused on sexual health and intimacy during pregnancy. The other group will review a standard educational article from the American College of Obstetricians and Gynecologists (ACOG) about sexual activity during pregnancy. Participants will complete surveys before and after reviewing the educational material, as well as a follow-up survey two weeks later. These surveys will measure knowledge about sexual health during pregnancy, comfort discussing sexual concerns with healthcare providers, and sexual function. The goal of this study is to determine whether an interactive educational approach can better support pregnant individuals' understanding of sexual health and encourage open communication with healthcare providers during pregnancy.

Подробное описание

This is a prospective, randomized controlled study designed to evaluate the effectiveness of an interactive educational module on sexual health knowledge, comfort with communication, and sexual function during pregnancy.

Pregnant participants receiving routine prenatal care at the Loyola University Medical Center outpatient women's health clinic will be recruited during clinic visits. Eligible participants will be adults aged 18 years or older with a low-risk pregnancy at or beyond 12 weeks' gestation who are English-speaking and able to read English. Individuals with pregnancy complications requiring management by maternal-fetal medicine or with contraindications to sexual activity during pregnancy will be excluded.

Participants will be randomized in a 1:1 ratio to one of two study arms. The intervention group will complete a pre-test survey, view an interactive, evidence-based educational module addressing sexual health, intimacy, and common misconceptions during pregnancy, and then complete an immediate post-test survey. The control group will complete a pre-test survey, review a standard ACOG educational article on sexual activity during pregnancy, and then complete an immediate post-test survey. All participants will receive a follow-up survey two weeks after the initial intervention.

Primary outcomes include changes in knowledge about sexual health during pregnancy. Secondary outcomes include changes in comfort discussing sexual concerns with healthcare providers and changes in sexual function as measured by the Female Sexual Function Index (FSFI). Survey data will be collected electronically using REDCap and analyzed using a per-protocol approach.

Вмешательства

• Поведенческое Standard ACOG Educational Article
  A publicly available educational article from the American College of Obstetricians and Gynecologists (ACOG) titled "Is it Safe to Have Sex During Pregnancy?" providing general guidance on sexual activity during pregnancy
• Поведенческое Interactive Sexual Health Educational Module
  An interactive, web-based educational module designed to educate pregnant individuals on sexual function, intimacy, and safe sexual practices during pregnancy. The module addresses common myths, physiological changes, communication with partners and healthcare providers, and evidence-based guidance regarding sexual activity during pregnancy.

Первичные конечные точки

• Change in Sexual Health Knowledge During Pregnancy [Срок оценки: Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention]

Вторичные конечные точки (2)

• Change in Comfort Discussing Sexual Health With Healthcare Providers [Срок оценки: Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention]
• Change in Sexual Function During Pregnancy [Срок оценки: Baseline (pre-test) and 2 weeks post-intervention]

Критерии участия

Критерии включения

• Pregnant individuals at or beyond 12 weeks gestation
• Age 18 years or older
• English speaking with English reading proficiency
• Experiencing a low risk pregnancy with no major complications
• Not currently followed by Maternal-Fetal Medicine (MFM) for high risk pregnancy management

Критерии исключения

• Pregnancy complications requiring management by Maternal-Fetal Medicine (MFM)
• Placed on pelvic rest
• Advised by their provider to abstain from sexual intercourse

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Loyola University Medical Center — Maywood

Публикации

• Aksoy Derya Y, Gok Ugur H, Ozsahin Z. Effects of demographic and obstetric variables with body image on sexual dysfunction in pregnancy: A cross-sectional and comparative study. Int J Nurs Pract. 2020 Jun;26(3):e12829. doi: 10.1111/ijn.12829. Epub 2020 Mar 10. PMID 32155306
• 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. PMID 23718891
• Mohammadi M, Khani M. Comparing the effect of face-to-face education and using educational films on couples' sexual dysfunction during pregnancy. J Educ Health Promot. 2021 Sep 30;10:335. doi: 10.4103/jehp.jehp_1535_20. eCollection 2021. PMID 34761021
• Bartellas E, Crane JM, Daley M, Bennett KA, Hutchens D. Sexuality and sexual activity in pregnancy. BJOG. 2000 Aug;107(8):964-8. doi: 10.1111/j.1471-0528.2000.tb10397.x. PMID 10955426
• Cassis C, Mukhopadhyay S, Morris E, Giarenis I. What happens to female sexual function during pregnancy? Eur J Obstet Gynecol Reprod Biol. 2021 Mar;258:265-268. doi: 10.1016/j.ejogrb.2021.01.003. Epub 2021 Jan 15. PMID 33485263
• Bahrami Vazir E, Mohammad-Alizadeh-Charandabi S, Kamalifard M, Ghelichkhani F, Mohammadi A, Mirghafourvand M. The correlation between sexual dysfunction and intimate partner violence in young women during pregnancy. BMC Int Health Hum Rights. 2020 Sep 14;20(1):24. doi: 10.1186/s12914-020-00245-9. PMID 32928215

Идентификаторы

NCT: NCT07497971 · 219476

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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