Sexual Functions and Marital Adjustment for Spouses in Menopause

Menopause Clinical Trial

— menopause  

Official title:

The Effect of Menopause on the Sexual Functions and Marital Adjustment of the Spouses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338645
• Other study ID #: 2017-38
• Status: Completed
• Start date: September 14, 2017
• Est. completion date: May 18, 2019

Study information

• Verified date: April 2022
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Objective: This study was conducted as a cross-sectional descriptive study in order to determine the effect of menopause on the SFs and marital adjustment of the spouses.

Description:

Objective: This study was conducted as a cross-sectional descriptive study in order to determine the effect of menopause on the SFs and marital adjustment of the spouses.

Materials and Methods: The sample of the study consisted of a total of 254 people, 127 of whom were postmenopausal women and their spouses. The data were collected with The Descriptive Information Form (DIF), The Female Sexual Function Scale (FSFS) and the Arizona Sexual Experiences Scale (ASES), The Marital Adjustment Scale (MAS). T test was used for two-group comparison of parametric data, Mann Whitney U test was used for two-group comparison of non-parametric data, and Kruskal Wallis Test was used for non-parametric data comparison of more than two groups. In addition, the relationship between the mean scores of FSFS, ASES and MAS was evaluated with Spearman's rho Correlation analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: May 18, 2019
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• The sample of the study consisted of women aged between 45-65,

• who were aged between 45-65,

• had at least 1 year of menopause,

• had no communication barriers,

• volunteered to participate in the research, -lived in the same house with their spouses, -

• had sexual activity in the last four weeks,

• selected using the simple random sampling method.

Exclusion Criteria:

• have diabetes,

• have hypertension,

• have depression

Related Conditions & MeSH terms

• Menopause

Locations

Country	Name	City	State
Turkey	Fatma Yildirim	Çorum

Sponsors (1)

Lead Sponsor	Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive Information Form (DIF)	Descriptive Information Form (DIF) was developed by the researcher according to the literature. This form was applied to 20 women who met the inclusion criteria of the research during the pre-application stage and was rearranged in terms of content and language validity (Bozkurt & Sevil, 2016). This form consists of questions to reveal some characteristics of socio-demographic and marital history such as age, education level, employment status, health insurance, monthly total income, marriage age, duration of marriage, and having children. It was composed of 31 questions in total, including questions to reveal some characteristics of menopause and SFs, such as the status and duration of replacement therapy (HRT), post-menopausal sexual problems, and the status of receiving sexual counseling. During the pre-application stage, DIF was applied to 20 women who met the inclusion criteria and was rearranged in terms of scope and language validity.	3 mounths
Primary	Female Sexual Functioning Scale (FSFS)	Female Sexual Functioning Scale (FSFS) is a 19-item scale developed by Rosen et al. (2000) to measure SFs in women in the last 4 weeks. The scale was adapted into Turkish by Aygin and Eti (2005). The Cronbach Alpha Coefficient of the scale is 0.75, and the Cronbach Alpha coefficient for the subscales is between 0.89 and 0.98 (Aygin & Aslan, 2005). In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication, orgasm, satisfaction, pain or discomfort. Scoring of the answers is between 1-5 points, and not having sexual intercourse in the last 4 weeks is evaluated as 0 points. The highest score that can be obtained from the scale is 95, and the lowest score is 4. After the subscale means are multiplied by the factor loads, the highest score that can be obtained from the scale is 36 and the lowest score is 2. The cut-off point of the scale is 26.55. Those with a score below 26.55 from the scale are considered to be SDs (Aygin & Aslan, 2005).	3 mounths
Primary	Arizona Sexual Experiences Scale-Male Form (ASES)	Arizona Sexual Experiences Scale Male Form (ASES) is a 5-item Likert-type scale developed by McGahuey et al. (2000) to evaluate SFs in men. The scale was adapted into Turkish by Atilla Soykan (2002). The Cronbach's Alpha coefficient of the scale was determined as 0.89 (Soykan, 2004). In the structure of the scale; There are 5 sub-dimensions: arousal, arousal, penile hardening, ability to reach orgasm, and satisfaction from orgasm. Each item is scored between 1-6 and the total score varies between 5 and 30. Low scores indicate enhanced sexual function and high scores indicate SD. The cut-off point of the scale is 11. A score of 11 and above is considered as SD.	3 mounths
Primary	Marriage Adjustment Scale (MAS)	Marriage Adjustment Scale (MAS) is a 15-item Likert-type scale developed by Locke and Wallace (1959) to evaluate marital satisfaction and MA level. It was adapted into Turkish by Tutarel and Kislak (1999) and the Cronbach's Alpha coefficient was found to be 0.83 for men and 0.84 for women. As the score obtained from the scale increases, MA also increases. Accordingly, the lowest score that can be obtained from the scale is 2, and the highest score is 158. The cut-off point of the scale is 43.5. Those who have a score below 43.5 from the scale are considered to have low MA.	3 mounths