- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07261943
The Effect of Sexual Counseling Based on the BETTER Model on Sexual Function and Quality of Sexual Life in Postmenopausal Women
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Karaman, Turkey (Türkiye)
- Karamanoglu Mehmetbey University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
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Experimental: experimental group
The group that received sexual education based on the BETTER model
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring the impact of sexual counseling based on the BETTER model
Time Frame: two months
|
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. |
two months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karamanoğlu Mehmetbey Universi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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