The Effect of Sexual Health Education Given to Women in the Postmenopausal Period on Sexual Life

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.

Study Overview

• Status: Recruiting
• Conditions: Menopause; Sexual Behavior; Sexuality
• Intervention / Treatment: Other: SEXUAL HEALTH EDUCATION

Detailed Description

Establishment of the Study Group: The Female Sexual Function Index (FSFI) was applied to the women who applied to the Obstetrics and Gynecology outpatient clinics of Karaman Training and Research Hospital to determine the study group, and the women who accepted to participate in the study in accordance with the sample selection criteria were applied to the study. General information about the study will be given and general consent will be taken for participation in the research. Then, the Individual Information Form, Sexual Myths Scale (SMS), Female Sexual Distress Scale (Revised- FSDS-R) and Sexual Life Quality Scale-Female (SILK-F) was applied. In accordance with the sample size determined by power analysis, the experimental and control groups were randomly assigned.

blinding Since it is not possible to blind the experimental and control groups in the study, only statistical blinding applied.

Application Steps of the Research Researcher; By introducing themselves to the experimental and control groups, verbal and written information was given about the subject of the research and the steps to be followed. Then, among the women determined by the researcher in accordance with the sample selection criteria, applications were made to the women who were allocated to the experimental group by randomization, and no intervention was made to those who were allocated to the control group.

For the Experimental Group; Sexual Health Education Program The women in the experimental group were given training in line with the "Sexual Health Education Manual for Postmenopausal Women" prepared by the researchers. The training plan of the research is as follows.

Education Plan (Sexual Health Education) Session Subject

1. Female reproductive organs (Female internal and external reproductive organs and sexual anatomy), Male reproductive organs and sexual anatomy Definitions related to sexuality and sexual health (sexuality, sexual health, sexual intimacy, sexual intercourse, sexual behaviors, sexual function, sexual dysfunction)
2. Sexual myths and taboos, sexual distress, sexual quality of life Female sexual function physiology and sexual response cycle, female sexual dysfunctions
3. Definition of menopause, classification of menopause, factors affecting menopause, the effect of menopause on sexual life, changes in the postmenopausal period and its effect on sexual life
4. Recommendations about changes in the postmenopausal period and sexual problems Kegel exercises, masturbation exercises

For the Control Group; Control Group: No intervention was made after the pre-tests were applied to the control group women. However, after the post-tests were applied, a sexual health education and training booklet was given to the control group, taking into account the right to be informed in terms of ethics.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serap KIRICI, MSc; Phone Number: 05436494623; Email: adlicann23@gmail.com
• Study Contact Backup: Name: Emel Ege, Professor; Phone Number: 05337755519; Email: emelege@hotmail.com

Study Locations

• Turkey
  • Karaman, Turkey
    • Recruiting
    • Karamanoğlu Mehmetbey University
    • Contact: Serap Kırıcı, Investigator; Phone Number: 05436494623; Email: adlicann23@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 39 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Training group; women in the intervention group will be given sexual health education once a week for 4 weeks	Other: SEXUAL HEALTH EDUCATION; Women in the intervention group will be given sexual health education once a week for 4 weeks
No Intervention: No Intervention: control group; Women will be monitored without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Distress Scale-Revised- FSDS- R	Female Sexual Distress Scale, Derogatis et al. (2008) to measure personal distress related to sexuality in women with sexual dysfunction. Responses to the items on the Likert-type scale consist of never (0), rarely (1), sometimes (2), often (3), or always (4). The lowest score that can be obtained from the FSDS-R is "0" and the highest score is "52". Higher scores indicate higher levels of sexual distress. FSDS-R will be used to assess sexual myths in each participant.	Time Frame: 13 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Quality of Life Questionnaire-Female (SQLQ-F)	Symonds et al. It was developed by in 2005 to assess the quality of sexual life in women. The scale is easy to apply, six-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. A high score from the scale indicates that the quality of sexual life is in good condition. SQLQ-F will be used to assess the quality of sexual life in each participant.	Time Frame: 13 weeks

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Study Director: Emel Ege, Professor, Necmettin Erbakan University; Principal Investigator: Serap Kırıcı, Investigator:, Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): September 27, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 24, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: sexual health; sexuality; postmenapause
• Other Study ID Numbers: KMUserapkirici

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No