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

NCT06772883 | Completed DMC

• 1 other identifier: MARMARAU-SBE-OBD-02
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contraception; Female Sexual Function; Sexual Dysfunction; PLISSIT; Training-consulting

Keywords

contraception; female sexual function; sexual dysfunction; PLISSIT; training-consulting

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI)

  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

Study Arms (2)

Experimental : Participant Group

EXPERIMENTAL

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.

Behavioral: sexual education and counseling

Control Group

OTHER

Routine clinical care

Other: control group

Interventions

sexual education and counseling 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.

Experimental : Participant Group

control group OTHER

routine clinical care

Control Group

Eligibility Criteria

• Age: Up to 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Counseling; Control Groups

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; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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: PhDc

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: May 2, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 30, 2019
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)