MenopausemenopauseNCT05338645
Sexual Functions and Marital Adjustment for Spouses in Menopause
An observational study of Menopause, run by Hitit University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Menopause
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2017to 18 May 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- have diabetes,
- have hypertension,
- have depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Menopause on the Sexual Functions and Marital Adjustment of the Spouses
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.
Read the detailed 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.
- Conditions
- Menopause
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start14 Sep 2017
- Primary completion14 Jun 2018
- Study completion18 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yildirim, Hitit University
- Investigators
- Fatma Yıldırım, Principal investigator, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338645
- Sponsor's protocol ID
- 2017-38
- Acronym
- menopause
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menopause on the Sexual Functions and Marital Adjustment of the Spouses
- ClinicalTrials.gov ID
- NCT05338645
- Acronym / sponsor ID
- menopause / 2017-38
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 18 May 2019 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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, -
Key exclusion criteria (3 listed)
- have diabetes,
- have hypertension,
- have depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive Information Form (DIF)
Time frame: 3 mounths
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.
Female Sexual Functioning Scale (FSFS)
Time frame: 3 mounths
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).
Arizona Sexual Experiences Scale-Male Form (ASES)
Time frame: 3 mounths
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.
Marriage Adjustment Scale (MAS)
Time frame: 3 mounths
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Yıldırım principal investigator
Hitit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive Information Form (DIF) (time frame: 3 mounths). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.