ContraceptionNCT06772883
The Effect of Sexual Education-Counseling According to PLISSIT in Solving Sexual Problems in Women Using Contraceptive Methods: One Year Follow-up Results
A study testing sexual education and counseling in people with Contraception and Female Sexual Function, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Female Sexual Function, Sexual Dysfunction
- What is being tested?
- sexual education and counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 46 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ≤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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- sexual education and counseling, control group
- Keywords
- contraception, female sexual function, sexual dysfunction, PLISSIT, training-consulting
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexual education and counselingBehavioural
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 groupOther
routine clinical care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: sexual education and counseling |
| Control Group | Other | Routine clinical care Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: initial, 1st, 1st, 3rd, 6th months and 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start2 May 2018
- Primary completion1 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem BAKAN DEMİREL, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772883
- Sponsor's protocol ID
- MARMARAU-SBE-OBD-02
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Education-Counseling According to PLISSIT in Solving Sexual Problems in Women Using Contraceptive Methods: One Year Follow-up Results
- ClinicalTrials.gov ID
- NCT06772883
- Acronym / sponsor ID
- MARMARAU-SBE-OBD-02
- Keywords
- contraception, female sexual function, sexual dysfunction, PLISSIT, training-consulting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : Participant Group | Experimental | Behavioral: sexual education and counselingThe 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 | Other | Other: control groupRoutine clinical care |
Who may qualify
- Ages
- Up to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- ≤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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sexual education and counselingThe 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. | Behavioural | Experimental : Participant Group |
| control grouproutine clinical care | Other | Control Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexual education and counseling in people with Contraception and Female Sexual Function, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) (time frame: initial, 1st, 1st, 3rd, 6th months and 1 year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.