The Effect of Sexual Education-Counseling According to PLISSIT Model of Couples' Sexual Functions During Pregnancy and Postpartum

NCT06762301 | Active Not Recruiting DMC

• 1 other identifier: MARMARAU-SBE-OBD-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Sexuality is a natural part of human life at every stage of life. It is a multidimensional phenomenon influenced by biological, psychological, social, interpersonal and cultural factors. Pregnancy is an extremely important process that occurs as a result of a sexual relationship and affects the lives of the woman and the couple. Many studies in the literature clearly show that sexual life is affected during pregnancy and postpartum period. In this context, it is stated that sexual health assessment, sexual education and counseling in pregnant/couples can be addressed in the early stages of pregnancy to reduce the anxiety of couples and the likelihood of sexual problems. It is important to evaluate sexual health during pregnancy and postpartum and to provide counseling and support in line with the results. In order to evaluate pregnancy and postpartum processes appropriately, the sexual history of women/couples should be defined. Therefore, it is important to learn the pre-pregnancy history of women/couples regarding their sexual activities and current sexual functions, to determine whether they experience sexual dysfunction during pregnancy or postpartum, and to examine its role in pregnancy and postpartum period, if any.

Conditions

Pregnancy; Postpartum Period; Sexual Dysfunction; PLISSIT Model; Sexual Counselling

Keywords

pregnancy; postpartum period; sexual dysfunction; PLISSIT model; sexual counselling

Outcome Measures

Primary Outcomes (2)

• Female Sexual Function Index (FSFI)

  According to the Female Sexual Function Index (FSFI) cut-off value to be applied to each sampled pregnant woman at the first encounter, pregnant women with a total score ≤26.55, that is, pregnant women with sexual dysfunction, will be identified.

  15 Months

• The International Erectile Function Evaluation Form (IIEF)

  The International Erectile Function Evaluation Form (IIEF) is evaluated in 5 categories in terms of erectile function. These are; severe erectile dysfunction (ED) score (6-10), moderate ED score (11-16), moderate-mild ED score (17-21), mild ED score (22-25), no ED (26-30) (Cappelleri et al., 1999). The scores that can be obtained as a result of IIEF evaluation are between 5-75. Cut-off value is not specified.

  15 Months

Study Arms (2)

Participant Group

EXPERIMENTAL

After the initial evaluation, pregnant women who will be included in the study group will be given an appointment for 1 week later, they will be asked to come with their partners and couples will be given sexual education and counseling in line with the PLISSIT model. After the initial evaluation, couples will be interviewed in the 1st, 2nd and 3rd trimesters, their sexuality since the previous evaluation according to the PLISSIT model, their problems, if any, will be discussed and short counseling will be given if necessary. In the first 4 weeks after delivery, couples in the study group will receive sexual education and counseling for the postpartum period in line with the PLISSIT model. They will be interviewed at the 3rd and 6th month after delivery and their postpartum sexuality and problems, if any, will be discussed and the sexual functions of the couples for the last 4 weeks will be evaluated.

Behavioral: sexual education and counseling

Control Group

OTHER

Routine clinical care

Other: Routine clinical care

Interventions

sexual education and counseling BEHAVIORAL

After the initial evaluation, pregnant women who will be included in the study group will be given an appointment for 1 week later, they will be asked to come with their partners and couples will be given sexual education and counseling in line with the PLISSIT model. After the initial evaluation, couples will be interviewed in the 1st, 2nd and 3rd trimesters, their sexuality since the previous evaluation according to the PLISSIT model, their problems, if any, will be discussed and short counseling will be given if necessary. In the first 4 weeks after delivery, couples in the study group will receive sexual education and counseling for the postpartum period in line with the PLISSIT model. They will be interviewed at the 3rd and 6th month after delivery and their postpartum sexuality and problems, if any, will be discussed and the sexual functions of the couples for the last 4 weeks will be evaluated.

Participant Group

Routine clinical care OTHER

Control Group

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For a pregnant woman;
• A woman who had just received the result of a pregnancy test and was referred to the family health center due to a positive pregnancy,
• Who wants the pregnancy to continue,
• In the first 6-8 gh. of gestation,
• FSFI cut-off value for pre/conceptional period with a total score ≤26.55,
• The one with a single, healthy fetus,
• Has a sexual partner and has an active sexual life,
• For the pregnant woman and her partner/partner;
• Educated enough to understand what they read and answer questions,
• Do not have chronic diseases that may affect sexual health (cancer, diabetes, hypertension, hypercholesterolemia, heart disease, atherosclerosis, chronic pulmonary and hepatic diseases, chronic renal failure, mental disorder, etc.) or continuous drug use (antihypertensive, diuretic, lipid-lowering agent, H2 receptor antagonist, antihistamine, anticholinergic, chemotherapeutic agent, anticonvulsant, antidepressant, antipsychotic, narcotic, sedative, etc.) and
• Pregnant women and their spouses who volunteered to participate in the study

You may not qualify if:

• Not planning to continue the pregnancy / planning to terminate the pregnancy,
• Who has completed the first trimester of pregnancy,
• FSFI cut-off value for pre/conceptional period with a total score \>26.55
• No active sex life,
• With language problems,
• Not educated enough to understand what they read and answer questions,
• Chronic illness or medication that may affect sexuality,
• Those who did not want to participate in the study and
• Pregnant women and their partners who wanted to leave the study voluntarily at any stage of the study / who felt uncomfortable with the questions asked during the study, or who discontinued the study

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Marmara University: collaborator

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Counseling

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd candidate

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: March 20, 2023
• Primary Completion: October 30, 2024
• Study Completion: June 30, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)