NCT05338645

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

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

September 14, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

April 14, 2022

Last Update Submit

April 14, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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 Aygın 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 (Aygın \& 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 (Aygın \& Aslan, 2005).

    3 mounths

  • 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

  • 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 Kışlak (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

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of this study, which was planned as a cross-sectional descriptive study, consisted of women who applied to the menopause polyclinic of a university hospital between 08.11.2017 and 29.12.2017. The sample of the study consisted of women aged between 45-65 years. Accordingly, the number of couples to be taken into the sample was determined as 125, and a total of 254 individuals, 127 of whom were menopausal women and their spouses, were included in the study.

You may qualify if:

  • 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.

You may not qualify if:

  • have diabetes,
  • have hypertension,
  • have depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Yıldırım

Çorum, 19600, Turkey (Türkiye)

Location

Study Officials

  • Fatma Yıldırım

    Hitit University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 21, 2022

Study Start

September 14, 2017

Primary Completion

June 14, 2018

Study Completion

May 18, 2019

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations