- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06772883
The Effect of Sexual Education-Counseling According to PLISSIT in Solving Sexual Problems in Women Using Contraceptive Methods: One Year Follow-up Results
January 11, 2025 updated by: Özlem BAKAN DEMİREL, Izmir Katip Celebi University
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
352
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İstanbul, Turkey
- Marmara University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control Group
Routine clinical care
|
routine clinical care
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female Sexual Function Index (FSFI)
Time Frame: initial, 1st, 1st, 3rd, 6th months and 1 year later
|
The FSFI total score ranges from 2 to 36 and the FSFI total score indicates the general status of sexual function.35
The FSFI cut-off value is 26.55.
A score of ≤26.55 defines sexual dysfunction and >26.55 defines normal sexual function.
|
initial, 1st, 1st, 3rd, 6th months and 1 year later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2018
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 30, 2019
Study Registration Dates
First Submitted
January 8, 2025
First Submitted That Met QC Criteria
January 11, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 11, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- MARMARAU-SBE-OBD-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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