NCT05560178

Brief Summary

With this study, it is aimed to evaluate the effect of sexual health education given to women in the postmenopausal period on sexual myths, sexual distress and sexual quality of life. Type of Research The study was planned as a parallel group (experiment-control) randomized controlled trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 7, 2022

Last Update Submit

September 24, 2022

Conditions

SexualityMenopauseSexual Behavior

Keywords

sexualitysexual healthpostmenapause

Outcome Measures

Primary Outcomes (1)

  • Sexual Myths Scale-SMS

    It is a scale developed to describe sexual myths. The minimum score obtained from the scale is 28, and the maximum score is 140. The cronbach's alpha coefficient of the scale was found to be 0.91. In addition, the sub-dimensions' item scores can be summed to obtain sub-dimensions' scores. It is not the cut-off point of the scale, and the high score indicates that the sexual myths are high. The Sexual Myths Scale-SMS will be used to assess sexual myths in each participant.

    Time Frame: 13 weeks

Secondary Outcomes (1)

  • Female Sexual Distress Scale-Revised- FSDS- R

    Time Frame: 13 weeks

Other Outcomes (1)

  • Sexual Quality of Life Questionnaire-Female (SQLQ-F)

    Time Frame: 13 weeks

Study Arms (2)

Experimental: Training group

EXPERIMENTAL

women in the intervention group will be given sexual health education once a week for 4 weeks

Other: SEXUAL HEALTH EDUCATION

No Intervention: control group

NO INTERVENTION

Women will be monitored without any intervention

Interventions

SEXUAL HEALTH EDUCATIONOTHER

Women in the intervention group will be given sexual health education once a week for 4 weeks

Experimental: Training group

Eligibility Criteria

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

You may qualify if:

  • Literate,
  • Able to communicate verbally,
  • Turkish speaking,
  • No hearing or vision loss,
  • Voluntarily participated in the research,
  • Postmenopausal period,
  • Natural menopause,
  • no sexual dysfunction,
  • be less than 65 years old,
  • good sexual function

You may not qualify if:

  • Hormone replacement therapy
  • Early menopause (before age 40)
  • A chronic systemic disease and/or a psychiatric health problem
  • Any sexual education before or during work
  • Sexual dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoğlu Mehmetbey University

Karaman, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

SexualitySexual Behavior

Interventions

Sex Education

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

SexologyBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Emel Ege, Professor

    Necmettin Erbakan University

    STUDY DIRECTOR

  • Serap Kırıcı, Investigator:

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serap KIRICI, MSc

CONTACT

05436494623adlicann23@gmail.com

Emel Ege, Professor

CONTACT

05337755519emelege@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Since it is not possible to blind the experimental and control groups in the study, only statistical blinding will be applied.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Research, parallel group (experiment-control) randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 29, 2022

Study Start

April 1, 2022

Primary Completion

September 27, 2022

Study Completion

April 1, 2023

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)