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| Name | Class |
|---|---|
| The international society for the study of women's sexual health | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Interactive Educational Module | Experimental | Participants assigned to this arm will complete a pre-test survey, review an interactive, evidence-based online educational module focused on sexual health, intimacy, and common misconceptions during pregnancy, and then complete an immediate post-test survey. A follow-up survey will be completed two weeks later. |
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| Arm 2: Standard Educational Article | Active Comparator | Participants assigned to this arm will complete a pre-test survey, review a standard educational article from the American College of Obstetricians and Gynecologists (ACOG) on sexual activity during pregnancy, and then complete an immediate post-test survey. A follow-up survey will be completed two weeks later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard ACOG Educational Article | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sexual Health Knowledge During Pregnancy | Change in participant knowledge regarding sexual health, intimacy, and safety of sexual activity during pregnancy, as measured by a study-specific knowledge survey administered before and after the educational intervention. The outcome is defined as the number of correct responses, with scores ranging from 0 to the total number of survey questions; higher scores indicate greater sexual health knowledge. | Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Comfort Discussing Sexual Health With Healthcare Providers | Change in participant-reported comfort discussing sexual health concerns with healthcare providers, as measured using a 5-point Likert scale ranging from 1 ("Not at all comfortable") to 5 ("Extremely comfortable"). Higher scores indicate greater comfort discussing sexual health with healthcare providers. | Baseline (pre-test), immediately post-intervention, and 2 weeks post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Lynn, DO | Contact | 708-327-1450 | MLYNN@lumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary Lynn, DO | Loyola University Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32155306 | Background | 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. | |
| 23718891 | Background | 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. |
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Individual participant data will not be shared. The study team does not have plans or infrastructure in place to support external data sharing, and the informed consent does not include provisions for sharing de-identified participant-level data outside the research team.
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Participants are randomly assigned to either an interactive educational module or a standard educational article, with outcomes assessed through pre-test, post-test, and two-week follow-up surveys.
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| Interactive Sexual Health Educational Module | Behavioral | 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. |
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| Change in Sexual Function During Pregnancy | Change in sexual function as measured by the Female Sexual Function Index (FSFI), a validated 19-item questionnaire assessing female sexual function. Total FSFI scores range from 2 to 36, with higher scores indicating better sexual function. Change in FSFI total score will be assessed following exposure to the educational intervention or control article. | Baseline (pre-test) and 2 weeks post-intervention |
| 34761021 | Background | 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. |
| 10955426 | Background | 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. |
| 33485263 | Background | 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. |
| 32928215 | Background | 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. |