NCT07261943

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

September 22, 2025

Last Update Submit

November 29, 2025

Conditions

Keywords

BETTER modelsexualitysexual education

Outcome Measures

Primary Outcomes (1)

  • 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

    two months

Secondary Outcomes (1)

  • Measuring the impact of sexual counseling based on the BETTER model

    two months

Study Arms (2)

control group

NO INTERVENTION

experimental group

EXPERIMENTAL

The group that received sexual education based on the BETTER model

Other: The group that received sexual education based on the BETTER model

Interventions

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.

experimental group

Eligibility Criteria

Age41 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual BehaviorSexuality

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 22, 2025

First Posted

December 3, 2025

Study Start

February 12, 2024

Primary Completion

May 15, 2025

Study Completion

September 12, 2025

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations