The Effect of Sexual Education-Counseling According to PLISSIT in Solving Sexual Problems in Women Using Contraceptive Methods: One Year Follow-up Results

NCT ID: NCT06772883

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2019-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Sexuality is a universal part of human life and is a process in which two people share their emotions, body, soul and pleasures. Although it is a natural part of life, sexuality can be affected by many factors. One of these factors is the contraceptive methods used by couples. While contraceptive methods prevent unplanned/unwanted pregnancies and help couples to have a satisfying sexual life without the fear of becoming pregnant, they can also negatively affect the sexuality of couples and even cause sexual dysfunctions.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Although there are many studies in the literature examining the changes of contraceptive methods on sexual behaviors, the relationship between method use and female sexual function remains unclear. There are studies showing that contraceptive method use has negative effects on sexual function (decreased frequency of sexual intercourse, difficulty in arousal, orgasm or lubrication), as well as studies suggesting that it may improve sexual behaviors. Some studies report that the contraceptive method used has no effect on sexual function.In contraceptive counseling, it is important to evaluate the sexual functions of the applicant and provide sexual counseling when necessary. It is recommended that health professionals use a model to effectively evaluate sexual functions and provide the most appropriate care in the presence of CD. In this direction, the education-counseling provided with the PLISSIT model, which is frequently used in this direction, can be an approach that can bridge the gap between the health professional and the individual in the elimination of CD.There are studies showing that sexual education-counseling using this model is effective. However, the number of studies in the literature in which the PLISSIT model was used to solve the problems of women experiencing CD during contraceptive method use is very limited. In addition, there is no study evaluating the effectiveness of the training-counseling provided with this model for 1 year in the literature. With the aim of contributing to the literature in line with this need, this study aimed to examine the effect of sexual education-counseling given in line with the PLISSIT model on the solution of sexual problems in women using contraceptive methods in a one-year period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception Female Sexual Function Sexual Dysfunction PLISSIT Training-consulting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental : Participant Group

The women included in the Working Group were contacted by phone and invited to the hospital. Sexual education and counseling were provided in accordance with the PLISSIT model. A total of 5 interviews were conducted with the women, the first face-to-face interview and the subsequent ones by telephone. FSFI assessments in the study FSFI assessments were performed 5 times (initial, 1st, 3rd, 6th months and 1 year later). According to the PLISSIT model, their sexuality and any problems since the previous assessment were discussed and a short counseling was given if necessary.

Group Type EXPERIMENTAL

sexual education and counseling

Intervention Type BEHAVIORAL

The women included in the Working Group were contacted by phone and invited to the hospital. Sexual education and counseling were provided in accordance with the PLISSIT model. A total of 5 interviews were conducted with the women, the first face-to-face interview and the subsequent ones by telephone. FSFI assessments in the study FSFI assessments were performed 5 times (initial, 1st, 3rd, 6th months and 1 year later). According to the PLISSIT model, their sexuality and any problems since the previous assessment were discussed and a short counseling was given if necessary.

Control Group

Routine clinical care

Group Type OTHER

control group

Intervention Type OTHER

routine clinical care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sexual education and counseling

The women included in the Working Group were contacted by phone and invited to the hospital. Sexual education and counseling were provided in accordance with the PLISSIT model. A total of 5 interviews were conducted with the women, the first face-to-face interview and the subsequent ones by telephone. FSFI assessments in the study FSFI assessments were performed 5 times (initial, 1st, 3rd, 6th months and 1 year later). According to the PLISSIT model, their sexuality and any problems since the previous assessment were discussed and a short counseling was given if necessary.

Intervention Type BEHAVIORAL

control group

routine clinical care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≤45 years of age and not in the peri/postmenopausal period (not menopausal which is),
* Has a sexual partner and has an active sexual life,
* One of the effective contraceptive methods (IUD, COC, Condom; Injection method, implanaon) for ≥3 months,
* Turkish language is not a problem,
* Educated enough to understand what they read and answer questions,
* Chronic diseases that may affect sexual health (cancer, diabetes, hypertension, hypercholesterolemia, heart disease, atherosclerosis, chronic pulmonary and hepatic diseases, chronic renal failure, etc.) or medication (antihypertensive, diuretic, lipid-lowering agent, H2 receptor antagonist, antihistamine, anticholinergic, chemotherapeutic agent, anticonvulsant, antidepressant, antipsychotic, narcotic, sedative) with no use and
* Women who volunteered to participate in the study were included in the study sample.

Exclusion Criteria

* Applying for the first time/to use a new method,
* ≥46 years of age or menopausal,
* New to their current method (\<3 months),
* Those who do not have an active sex life or who have very infrequent sex due to their partner's job, etc. in a relationship,
* Chronic illness or medication that may affect sexuality,
* Who doesn't speak Turkish,
* Not educated enough to understand what they read and answer questions,
* Women who did not want to participate in the study were not included in the sample.
Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Izmir Katip Celebi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Özlem BAKAN DEMİREL

PhDc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MARMARAU-SBE-OBD-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sexual Health Education Given to Women
NCT07037602 ENROLLING_BY_INVITATION NA