PostmenopauseNCT07283146
The Effect of EX-PLISSIT Model-Based Sexual Counseling in Postmenopausal Women
A study testing EX-PLISSIT Model-Based Sexual Counseling in people with Postmenopause, run by NESLİHAN YILMAZ SEZER at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted in two groups as counseling and control. Participants will be approached at the Public Education Center. After postmenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained from… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- EX-PLISSIT Model-Based Sexual Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 29 Apr 2026
- 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 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postmenopausal, defined as having had no menstrual periods or vaginal bleeding in the last 12 months,
- Under 65 years of age,
- Married,
- Having entered menopause naturally,
- Able to understand, speak, and read Turkish.
Who cannot join
- Women with diagnosed conditions that may significantly affect sexual quality of life (such as diabetes, hypertension, heart disease, pulmonary diseases, cancer types, psychiatric disorders, or a history of neurological stroke),
- Women using medications known to negatively affect sexual function (including psychotropic drugs, cardiac and antihypertensive medications, anticonvulsants, opioids, antinarcotics, H2-receptor antagonists, and antihistamines),
- Those who have previously received or are currently receiving hormone replacement therapy,
- Those with a diagnosis of sexual dysfunction in themselves or their partners,
- Those who have experienced major stressful life events (such as an accident, trauma, or the death or severe illness of a close relative) within the three months prior to the study,
- Women with a serious impairment that affects their ability to complete data collection forms,
- Not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdagmadeni Public Education Center
Yozgat, 66300
About this study
Official title: The Effect of EX-PLISSIT Model-Based Sexual Counseling on Perceptions of Sexuality, Sexual Quality of Life, and Sexual Satisfaction in Postmenopausal Women
The study will be conducted in two groups as counseling and control. Participants will be approached at the Public Education Center. After postmenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained from those who agree. Random assignment of women to the study groups will be carried out using randomization.
This study aimed to determine the effects of sexual counseling based on the EX-PLISSIT model on sexual quality of life, sexual satisfaction, and perceptions of sexuality in postmenopausal women.
- Conditions
- Postmenopause
- Being tested
- EX-PLISSIT Model-Based Sexual Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EX-PLISSIT Model-Based Sexual CounselingOther
Women in the experimental group will receive sexual counseling based on the EX-PLISSIT model. The steps to be followed in accordance with this model are as follows:
Session 1 Permission Limited Information Specific Suggestions IT - Intensive Therapy
Session 2 At the beginning of the interview, the data collection forms will be re-administered, and the homework assigned in the first session will be discussed. The information needed by the woman, in line with her questions, will be provided within the steps of the EX-PLISSIT model: permission, limited information, specific suggestions, and, if necessary, intensive therapy. At the end of the second session, the women will be given an appointment for the final assessment to be conducted two months later.
Session 3 At the beginning of the interview, the data collection forms will be administered for the last time, the woman's questions (if any) will be answered, and the session will be concluded.
| Study group | Role | What they receive |
|---|---|---|
| Counseling Group | Experimental | Not described Receives: Other: EX-PLISSIT Model-Based Sexual Counseling |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual Life Quality
The scale is easy to apply, 6-point Likert type, which individuals can answer on their own, and consists of 18 items. Each item is expected to be answered considering the sexual life in the last four weeks. Each item of the scale is scored between 1 and 6. The items of the scale are scored as "I totally agree"=1, "I strongly agree"=2, "I partially agree"=3, "I partially disagree"=4, "I strongly disagree"=5, "I strongly disagree"=6 and 1 Questions 5, 9, 13 and 18 are reverse coded. The range of points that can be obtained from the scale is between 18-108.
Measured: Baseline, 1 month later and 3 months later
Change in sexual satisfaction
VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
Measured: Baseline, 1 month later and 3 months later
Change in sexuality perception
Sexuality Perception Scale in Menopause The 12-item, 5-point Likert-type scale consists of two subdimensions: Perceptions Restricting Sexuality and Perceptions Related to the Continuation of Sexual Life. The minimum possible score on the scale is 12, and the maximum score is 60. Higher scores indicate more positive perceptions regarding sexuality during menopause.
Measured: Baseline, 1 month later and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Dec 2025
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- NESLİHAN YILMAZ SEZER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NESLİHAN YILMAZ SEZER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283146
- Sponsor's protocol ID
- 18/242
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of EX-PLISSIT Model-Based Sexual Counseling on Perceptions of Sexuality, Sexual Quality of Life, and Sexual Satisfaction in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07283146
- Acronym / sponsor ID
- 18/242
- Conditions
- Postmenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- NESLİHAN YILMAZ SEZERUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 15 Dec 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.
The study will be conducted in two groups as counseling and control. Participants will be approached at the Public Education Center. After postmenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained from those who agree. Random assignment of women to the study groups will be carried out using randomization.
This study aimed to determine the effects of sexual counseling based on the EX-PLISSIT model on sexual quality of life, sexual satisfaction, and perceptions of sexuality in postmenopausal women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling Group | Experimental | Other: EX-PLISSIT Model-Based Sexual Counseling |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Postmenopausal, defined as having had no menstrual periods or vaginal bleeding in the last 12 months,
- Under 65 years of age,
- Married,
- Having entered menopause naturally,
- Able to understand, speak, and read Turkish.
Key exclusion criteria (7 listed)
- Women with diagnosed conditions that may significantly affect sexual quality of life (such as diabetes, hypertension, heart disease, pulmonary diseases, cancer types, psychiatric disorders, or a history of neurological stroke),
- Women using medications known to negatively affect sexual function (including psychotropic drugs, cardiac and antihypertensive medications, anticonvulsants, opioids, antinarcotics, H2-receptor antagonists, and antihistamines),
- Those who have previously received or are currently receiving hormone replacement therapy,
- Those with a diagnosis of sexual dysfunction in themselves or their partners,
- Those who have experienced major stressful life events (such as an accident, trauma, or the death or severe illness of a close relative) within the three months prior to the study,
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 |
|---|---|---|
| EX-PLISSIT Model-Based Sexual CounselingWomen in the experimental group will receive sexual counseling based on the EX-PLISSIT model. The steps to be followed in accordance with this model are as follows: Session 1 Permission Limited Information Specific Suggestions IT - Intensive Therapy Session 2 At the beginning of the interview, the data collection forms will be re-administered, and the homework assigned in the first session will be discussed. The information needed by the woman, in line with her questions, will be provided within the steps of the EX-PLISSIT model: permission, limited information, specific suggestions, and, if necessary, intensive therapy. At the end of the second session, the women will be given an appointment for the final assessment to be conducted two months later. Session 3 At the beginning of the interview, the data collection forms will be administered for the last time, the woman's questions (if any) will be answered, and the session will be concluded. | Other | Counseling Group |
Primary outcome
Change in Sexual Life Quality
Time frame: Baseline, 1 month later and 3 months later
The scale is easy to apply, 6-point Likert type, which individuals can answer on their own, and consists of 18 items. Each item is expected to be answered considering the sexual life in the last four weeks. Each item of the scale is scored between 1 and 6. The items of the scale are scored as "I totally agree"=1, "I strongly agree"=2, "I partially agree"=3, "I partially disagree"=4, "I strongly disagree"=5, "I strongly disagree"=6 and 1 Questions 5, 9, 13 and 18 are reverse coded. The range of points that can be obtained from the scale is between 18-108.
Change in sexual satisfaction
Time frame: Baseline, 1 month later and 3 months later
VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
Change in sexuality perception
Time frame: Baseline, 1 month later and 3 months later
Sexuality Perception Scale in Menopause The 12-item, 5-point Likert-type scale consists of two subdimensions: Perceptions Restricting Sexuality and Perceptions Related to the Continuation of Sexual Life. The minimum possible score on the scale is 12, and the maximum score is 60. Higher scores indicate more positive perceptions regarding sexuality during menopause.
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 5 May 2026.
- Individual participant dataSharing planned: No
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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 EX-PLISSIT Model-Based Sexual Counseling in people with Postmenopause, run by NESLİHAN YILMAZ SEZER 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 5 inclusion and 7 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 5 May 2026. 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?
Change in Sexual Life Quality (time frame: Baseline, 1 month later and 3 months later). The study lists 3 primary outcomes in all. 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 5 May 2026.