Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05560178
Other study ID # KMUserapkirici
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date April 1, 2023

Study information

Verified date September 2022
Source Necmettin Erbakan University
Contact Serap KIRICI, MSc
Phone 05436494623
Email adlicann23@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date April 1, 2023
Est. primary completion date September 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 41 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
SEXUAL HEALTH EDUCATION
Women in the intervention group will be given sexual health education once a week for 4 weeks

Locations

Country Name City State
Turkey Karamanoglu Mehmetbey University Karaman

Sponsors (1)

Lead Sponsor Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
See also
  Status Clinical Trial Phase
Completed NCT04553029 - A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
Completed NCT03672513 - Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04210583 - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Completed NCT05617287 - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause N/A
Recruiting NCT05180266 - Therapeutic Touch and Music in The Menopausal Period N/A
Recruiting NCT04043520 - Bioenergetic Effects of Aging and Menopause (BEAM) Phase 4
Completed NCT03663075 - Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women N/A
Completed NCT03363997 - Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days Phase 1
Not yet recruiting NCT04724135 - Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
Not yet recruiting NCT04728126 - Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
Completed NCT02274571 - Raising Insulin Sensitivity in Post Menopause Early Phase 1
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT02253173 - Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Phase 3
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Recruiting NCT01488903 - A Cohort Research of Genetic Susceptibility for Common Obesity in Women N/A
Terminated NCT01633814 - Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A