Sexual BehaviorNCT07261943
The Effect of Sexual Counseling Based on the BETTER Model on Sexual Function and Quality of Sexual Life in Postmenopausal Women
A study testing The group that received sexual education based on the BETTER model in people with Sexual Behavior and Climactericum, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Sexual life, an integral part of overall health, remains one of the most neglected, undervalued, and problematic areas within today's healthcare system Various management strategies exist for managing sexual dysfunction, including behavioral, psychological, and pharmacological strategies, and researchers have used… Read more about this study
- Who is it for?
- Ages 41 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Climactericum, Sexuality Education
- What is being tested?
- The group that received sexual education based on the BETTER model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2024to 12 Sep 2025
- 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 41 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who are married, sexually active, and have a regular sexual life
- Who are literate
- Who are postmenopausal (the time period between one year after menopause and old age within the WHO's definition of postmenopause)
- Who are more than one year postmenopause
- Who are not over 65 years of age, which is considered the age limit by the WHO -Who agree to participate in the study
- Who have entered menopause naturally-Who have scored ≤26.55 on the FSFI scale
Who cannot join
- Being on Hormone Replacement Therapy (HRT) and not having stopped at least six months before the study
- Having entered early menopause (before the age of 40)
- Having a chronic systemic disease and/or a psychiatric health problem
- Having a disability that makes communication difficult, such as hearing or language impairment
- Having received any sexual education before or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Sexual life, an integral part of overall health, remains one of the most neglected, undervalued, and problematic areas within today's healthcare system Various management strategies exist for managing sexual dysfunction, including behavioral, psychological, and pharmacological strategies, and researchers have used education and counseling interventions for this purpose. One such intervention is the BETTER model, which aims to collaborate with individuals experiencing sexual difficulties to address their problems. Discussing sexuality with individuals experiencing sexual difficulties and providing counseling services will significantly benefit healthcare professionals in promoting safe sexual practices, identifying existing or potential sexual problems, and addressing these issues
- Conditions
- Sexual Behavior, Climactericum, Sexuality Education
- Being tested
- The group that received sexual education based on the BETTER model
- Keywords
- BETTER model, sexuality, sexual education
- Medical subject headings
- Sexual Behavior, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group that received sexual education based on the BETTER modelOther
The women in the experimental group will be trained in groups of 5-6, in a designated classroom in the Department of Obstetrics and Gynecology at the relevant hospital, in four sessions, each lasting 45-60 minutes, with a one-week break. The training will utilize warm-up exercises, PowerPoint presentations, question-and-answer sessions, and discussions. All women in the training group will be given the opportunity to ask questions and express themselves. Evaluation of the training will be conducted through Q\&A and verbal feedback from the women, and further training will be provided on the requested topics based on their questions.No intervention will be made to the women in the control group after the pre-tests.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| experimental group | Experimental | The group that received sexual education based on the BETTER model Receives: Other: The group that received sexual education based on the BETTER model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the impact of sexual counseling based on the BETTER model
After sexual counseling based on the BETTER model, the Female Sexual Function Index (FSFI) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes.
Changes in the Female Sexual Function Index (FSFI) scale were measured two months after sexual counseling based on the BETTER model.
Female Sexual Function Index (FSFI) It was developed by Rosen et al. as a multidimensional scale comprising 19 items to evaluate female sexual function. The scale includes six subheadings, desire, arousal, lubrication, orgasm, satisfaction, and pain. Each title was scored between 0 or 1 and six. The lowest and highest scores are 2 and 36, respectively. Higher scores indicated better sexual function. The cut-off value of the scale was 26.55. A total FSFI score of ≤26.55, it indicates sexual dysfunction
Measured: two months
Secondary outcomes (1)
Measuring the impact of sexual counseling based on the BETTER model
After sexual counseling based on the BETTER model, the Sexual Quality of Life-Female (SQoL-F) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes.
Changes in the Female Sexual Quality of Life (SQoL-F) scales were measured two months after sexual counseling based on the BETTER model.
Sexual Quality of Life-Female (SQoL-F): Developed by Symonds et al., with Turkish validity and reliability conducted by Tuğut and Gölbaşı. It is a 6-point Likert-type scale with 18 items. Respondents consider their sexual life over the past four weeks. Scores range from 18 to 108. Higher scores indicate better sexual quality of life.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start12 Feb 2024
- Primary completion15 May 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Kırıcı, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261943
- Sponsor's protocol ID
- Karamanoğlu Mehmetbey Universi
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Counseling Based on the BETTER Model on Sexual Function and Quality of Sexual Life in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07261943
- Acronym / sponsor ID
- Karamanoğlu Mehmetbey Universi
- Conditions
- Sexual Behavior, Climactericum, Sexuality Education
- Keywords
- BETTER model, sexuality, sexual education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 3 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.
Sexual life, an integral part of overall health, remains one of the most neglected, undervalued, and problematic areas within today's healthcare system Various management strategies exist for managing sexual dysfunction, including behavioral, psychological, and pharmacological strategies, and researchers have used education and counseling interventions for this purpose. One such intervention is the BETTER model, which aims to collaborate with individuals experiencing sexual difficulties to address their problems. Discussing sexuality with individuals experiencing sexual difficulties and providing counseling services will significantly benefit healthcare professionals in promoting safe sexual practices, identifying existing or potential sexual problems, and addressing these issues
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| experimental group | Experimental | Other: The group that received sexual education based on the BETTER modelThe group that received sexual education based on the BETTER model |
Who may qualify
- Ages
- 41 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women who are married, sexually active, and have a regular sexual life
- Who are literate
- Who are postmenopausal (the time period between one year after menopause and old age within the WHO's definition of postmenopause)
- Who are more than one year postmenopause
- Who are not over 65 years of age, which is considered the age limit by the WHO -Who agree to participate in the study
Key exclusion criteria (5 listed)
- Being on Hormone Replacement Therapy (HRT) and not having stopped at least six months before the study
- Having entered early menopause (before the age of 40)
- Having a chronic systemic disease and/or a psychiatric health problem
- Having a disability that makes communication difficult, such as hearing or language impairment
- Having received any sexual education before or during 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 |
|---|---|---|
| The group that received sexual education based on the BETTER modelThe women in the experimental group will be trained in groups of 5-6, in a designated classroom in the Department of Obstetrics and Gynecology at the relevant hospital, in four sessions, each lasting 45-60 minutes, with a one-week break. The training will utilize warm-up exercises, PowerPoint presentations, question-and-answer sessions, and discussions. All women in the training group will be given the opportunity to ask questions and express themselves. Evaluation of the training will be conducted through Q\&A and verbal feedback from the women, and further training will be provided on the requested topics based on their questions.No intervention will be made to the women in the control group after the pre-tests. | Other | experimental group |
Primary outcome
Measuring the impact of sexual counseling based on the BETTER model
Time frame: two months
After sexual counseling based on the BETTER model, the Female Sexual Function Index (FSFI) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes. Changes in the Female Sexual Function Index (FSFI) scale were measured two months after sexual counseling based on the BETTER model. Female Sexual Function Index (FSFI) It was developed by Rosen et al. as a multidimensional scale comprising 19 items to evaluate female sexual function. The scale includes six subheadings, desire, arousal, lubrication, orgasm, satisfaction, and pain. Each title was scored between 0 or 1 and six. The lowest and highest scores are 2 and 36, respectively. Higher scores indicated better sexual function. The cut-off value of the scale was 26.55. A total FSFI score of ≤26.55, it indicates sexual dysfunction
1 secondary outcome
Measuring the impact of sexual counseling based on the BETTER model
Time frame: two months
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 3 Dec 2025.
- 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 The group that received sexual education based on the BETTER model in people with Sexual Behavior and Climactericum, run by Karamanoğlu Mehmetbey 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 6 inclusion and 5 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 3 Dec 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?
Measuring the impact of sexual counseling based on the BETTER model (time frame: two months). 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 3 Dec 2025.