ClinicalTrials.gg
CompletedNCT06772883Updated Jan 14, 2025

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

An interventional study of sexual education and counseling and control group in Contraception, Female Sexual Function and Sexual Dysfunction, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged Up to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 8 months after the study started (first participant enrolled May 2018, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
Up to 46 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • contraception
  • female sexual function
  • sexual dysfunction
  • PLISSIT
  • training-consulting
03

In context

Sexual Dysfunction, Physiological

126 studies on the registry are indexed under Sexual Dysfunction, Physiological; 45 are open to participants now.

This study's enrollment of 352 is above the median of 60 across 88 interventional studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
352 participants (actual)

Study arms

  • 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.

    Behavioral: sexual education and counseling

  • Other
    Control Group

    Routine clinical care

    Other: control group

Interventions

  • Behavioralsexual 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.

  • Othercontrol group

    routine clinical care

06

What researchers measure

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.

    Time frame: initial, 1st, 1st, 3rd, 6th months and 1 year later

07

Study locations

1 site
  • Marmara University
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06772883
Responsible party
Özlem BAKAN DEMİREL (PhDc, Marmara University) — Principal investigator
First posted
Jan 14, 2025
Start date
May 2, 2018
Primary completion
Aug 1, 2019
Completion
Aug 30, 2019
Last update
Jan 14, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion