Sexual DysfunctionNCT06337058
Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause Period
A study testing Experimental group (motivational interview) in people with Sexual Dysfunction, run by Hülya KAMALAK at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Experimental group (motivational interview)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 15 Dec 2022
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being able to read and write,
- Ability to communicate
- Being sexually active,
- Having entered menopause in the last 3 years,
- Having entered menopause naturally,
- Diagnosis of sexual dysfunction according to the Arizona Sexual Experiences Scale (total score ≥19).
Who cannot join
- Having any diagnosed psychiatric illness,
- Having entered menopause surgically,
- Being on hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutçu Imam University
Kahramanmaraş
About this study
Official title: The Effect of Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause on Quality of Sexual Life and Self-Efficacy
The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. It was calculated as 164 women (82 experimental, 82 control).In data collection, 'Personal Information Form (EK- )', 'Arizona Sexual Experiences Scale (ACYÖ) (EK- )', 'Sexual Quality of Life Scale-Female (SIQQ-F) (EK-)' and 'Sexual Self-Efficacy Scale' (Annex- )' was used.
Read the detailed description
Aim: This study was conducted to determine the effect of motivational interviewing on sexual quality of life and sexual self-efficacy in menopausal women with sexual dysfunction.
Methods: This randomized controlled study was conducted with 164 menopausal women with sexual dysfunction who applied to the gynecology outpatient clinic of a university hospital in southern Turkey (82 experimental, 82 control). The data were collected using a personal information form, the Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F), the Sexual Quality of Life-Female Questionnaire (SQOL-F) and the Sexual Self-Efficacy Scale (SSES). Menopausal women with sexual dysfunction (with a score of 19 and above on the ASEX-F) who applied to the gynecology outpatient clinic of the relevant hospital were invited to the study.
Before starting the motivational interviews with menopausal women in the experimental group; the PIF, the SQOL-F and the SSES were applied and their pre-test data were obtained. After the pre-test data were obtained, 4 sessions of motivational interviews were conducted with the women, 1 session per week for four weeks. Motivational interviews were completed with face-to-face interviews lasting 20-30 minutes for each woman, and those in the control group did not receive any intervention.
- Conditions
- Sexual Dysfunction
- Being tested
- Experimental group (motivational interview)
- Keywords
- Menopause Period, Motivational Interview, Sexual Dysfunction, Sexual Quality of Life, Midwifery
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group (motivational interview)Behavioural
For the menopausal women with sexual dysfunction in the experimental group, pre-test data were obtained by applying the 'Personal Information Form', the 'Sexual Quality of Life Scale-Woman' and the 'Sexual Self-Efficacy Scale' before starting the motivational interviews. After the pre-test data were obtained, a total of 4 sessions of motivational interviews were provided, one session per week for four weeks. At the end of four weeks, post-test data were obtained by applying the "Arizona Sexual Experiences Scale", "Sexual Quality of Life Scale-Women" and "Sexual Self-Efficacy Scale".
The researcher received a training on motivational interview techniques before implementing the intervention for menopausal women in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | intervention group Receives: Behavioral: Experimental group (motivational interview) |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F)
This Likert-type self-assessment scale, available in both female and male forms, consists of five items. Its internal consistency and reliability (Cronbach's alpha) values ranged from 0.89 to 0.90. It has been determined to be useful for detecting sexual dysfunction. Each item on the scale is scored from 1 to 6, with a total score ranging from 5 to 30. A total score of 19 or higher, any item scoring 5 or 6 points, or four or more items scoring 4 points indicate the presence of sexual dysfunction. Low scores represent an effective, comfortable, and satisfactory sexual response, while high scores indicate the presence of sexual dysfunction.
Measured: 1 day At the first interview, the Arizona Sexual Experiences Scale - Female Version Survey (ASEX-F) was administered to menopausal women in both groups as a pretest.
Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F)
This Likert-type self-assessment scale, available in both female and male forms, consists of five items. Its internal consistency and reliability (Cronbach's alpha) values ranged from 0.89 to 0.90. It has been determined to be useful for detecting sexual dysfunction. Each item on the scale is scored from 1 to 6, with a total score ranging from 5 to 30. A total score of 19 or higher, any item scoring 5 or 6 points, or four or more items scoring 4 points indicate the presence of sexual dysfunction. Low scores represent an effective, comfortable, and satisfactory sexual response, while high scores indicate the presence of sexual dysfunction.
Measured: Four week after the first interview, the Arizona Sexual Experiences Scale - Female Version Survey (ASEX-F) was applied to all menopausal women in all two groups as a posttest
Sexual Quality of Life-Female Questionnaire (SQOL-F)
The scale consists of a total of 18 items, requiring responses regarding sexual problems in the last 4 weeks. This is a Likert-type scale with six response options. For item scoring from 0 to 5, the minimum and maximum possible scores on the scale are 0 and 90, respectively. For item scoring between 1 and 6, the minimum and maximum possible scores on the scale are 18 and 108, respectively. In this study, the scoring system between 1 and 6 was used. Higher scores on the scale indicate a good quality of sexual life.
Measured: 1 day At the first interview, the Sexual Quality of Life-Female Questionnaire (SQOL-F) was administered to menopausal women in both groups as a pretest.
Sexual Quality of Life-Female Questionnaire (SQOL-F)
The scale consists of a total of 18 items, requiring responses regarding sexual problems in the last 4 weeks. This is a Likert-type scale with six response options. For item scoring from 0 to 5, the minimum and maximum possible scores on the scale are 0 and 90, respectively. For item scoring between 1 and 6, the minimum and maximum possible scores on the scale are 18 and 108, respectively. In this study, the scoring system between 1 and 6 was used. Higher scores on the scale indicate a good quality of sexual life.
Measured: Four week after the first interview, the Sexual Quality of Life-Female Questionnaire (SQOL-F) was applied to all menopausal women in all two groups as a posttest
Sexual Self-Efficacy Scale (SSES)
The SSES was developed by Humphreys and Kennett (2010), and its Turkish validity and reliability study was conducted by Çelik (2012). The 8-point Likert scale consists of 5 items, scoring from 1 = Strongly Disagree to 8 = Strongly Agree and representing a single factor. The self-reporting scale was developed to determine individuals' sexual self-efficacy, where total scores are obtained by reverse coding items 3 and 4. Higher scores on the scale indicate higher levels of sexual self-efficacy. Total scale score ranges between 5 and 40.The Cronbach's alpha coefficient for the scale is 0.71. In this study, the Cronbach's alpha reliability coefficient was found as 0.93 for the experimental group and 0.90 for the control group.
Measured: 1 day At the first interview, the Sexual Self-Efficacy Scale (SSES) was administered to menopausal women in both groups as a pretest.
Sexual Self-Efficacy Scale (SSES)
The SSES was developed by Humphreys and Kennett (2010), and its Turkish validity and reliability study was conducted by Çelik (2012). The 8-point Likert scale consists of 5 items, scoring from 1 = Strongly Disagree to 8 = Strongly Agree and representing a single factor. The self-reporting scale was developed to determine individuals' sexual self-efficacy, where total scores are obtained by reverse coding items 3 and 4. Higher scores on the scale indicate higher levels of sexual self-efficacy. Total scale score ranges between 5 and 40.The Cronbach's alpha coefficient for the scale is 0.71. In this study, the Cronbach's alpha reliability coefficient was found as 0.93 for the experimental group and 0.90 for the control group.
Measured: Four week after the first interview, the Sexual Self-Efficacy Scale (SSES) was applied to all menopausal women in all two groups as a posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Jun 2020
- Primary completion15 Jun 2021
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hülya KAMALAK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hülya KAMALAK, Kahramanmaras Sutcu Imam University
- Investigators
- Hülya KAMALAK, Phd, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337058
- Sponsor's protocol ID
- KSUHULYAKAMALAK001
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause on Quality of Sexual Life and Self-Efficacy
- ClinicalTrials.gov ID
- NCT06337058
- Acronym / sponsor ID
- KSUHULYAKAMALAK001
- Conditions
- Sexual Dysfunction
- Keywords
- Menopause Period, Motivational Interview, Sexual Dysfunction, Sexual Quality of Life, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Hülya KAMALAKUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 29 Mar 2024 (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.
The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. It was calculated as 164 women (82 experimental, 82 control).In data collection, 'Personal Information Form (EK- )', 'Arizona Sexual Experiences Scale (ACYÖ) (EK- )', 'Sexual Quality of Life Scale-Female (SIQQ-F) (EK-)' and 'Sexual Self-Efficacy Scale' (Annex- )' was used.
Detailed description
Aim: This study was conducted to determine the effect of motivational interviewing on sexual quality of life and sexual self-efficacy in menopausal women with sexual dysfunction.
Methods: This randomized controlled study was conducted with 164 menopausal women with sexual dysfunction who applied to the gynecology outpatient clinic of a university hospital in southern Turkey (82 experimental, 82 control). The data were collected using a personal information form, the Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F), the Sexual Quality of Life-Female Questionnaire (SQOL-F) and the Sexual Self-Efficacy Scale (SSES). Menopausal women with sexual dysfunction (with a score of 19 and above on the ASEX-F) who applied to the gynecology outpatient clinic of the relevant hospital were invited to the study.
Before starting the motivational interviews with menopausal women in the experimental group; the PIF, the SQOL-F and the SSES were applied and their pre-test data were obtained. After the pre-test data were obtained, 4 sessions of motivational interviews were conducted with the women, 1 session per week for four weeks. Motivational interviews were completed with face-to-face interviews lasting 20-30 minutes for each woman, and those in the control group did not receive any intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Experimental group (motivational interview)intervention group |
| control group | No intervention | –control group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Being able to read and write,
- Ability to communicate
- Being sexually active,
- Having entered menopause in the last 3 years,
- Having entered menopause naturally,
Key exclusion criteria (3 listed)
- Having any diagnosed psychiatric illness,
- Having entered menopause surgically,
- Being on hormone replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental group (motivational interview)For the menopausal women with sexual dysfunction in the experimental group, pre-test data were obtained by applying the 'Personal Information Form', the 'Sexual Quality of Life Scale-Woman' and the 'Sexual Self-Efficacy Scale' before starting the motivational interviews. After the pre-test data were obtained, a total of 4 sessions of motivational interviews were provided, one session per week for four weeks. At the end of four weeks, post-test data were obtained by applying the "Arizona Sexual Experiences Scale", "Sexual Quality of Life Scale-Women" and "Sexual Self-Efficacy Scale". The researcher received a training on motivational interview techniques before implementing the intervention for menopausal women in the experimental group. | Behavioural | experimental group |
Primary outcome
Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F)
Time frame: 1 day At the first interview, the Arizona Sexual Experiences Scale - Female Version Survey (ASEX-F) was administered to menopausal women in both groups as a pretest.
This Likert-type self-assessment scale, available in both female and male forms, consists of five items. Its internal consistency and reliability (Cronbach's alpha) values ranged from 0.89 to 0.90. It has been determined to be useful for detecting sexual dysfunction. Each item on the scale is scored from 1 to 6, with a total score ranging from 5 to 30. A total score of 19 or higher, any item scoring 5 or 6 points, or four or more items scoring 4 points indicate the presence of sexual dysfunction. Low scores represent an effective, comfortable, and satisfactory sexual response, while high scores indicate the presence of sexual dysfunction.
Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F)
Time frame: Four week after the first interview, the Arizona Sexual Experiences Scale - Female Version Survey (ASEX-F) was applied to all menopausal women in all two groups as a posttest
This Likert-type self-assessment scale, available in both female and male forms, consists of five items. Its internal consistency and reliability (Cronbach's alpha) values ranged from 0.89 to 0.90. It has been determined to be useful for detecting sexual dysfunction. Each item on the scale is scored from 1 to 6, with a total score ranging from 5 to 30. A total score of 19 or higher, any item scoring 5 or 6 points, or four or more items scoring 4 points indicate the presence of sexual dysfunction. Low scores represent an effective, comfortable, and satisfactory sexual response, while high scores indicate the presence of sexual dysfunction.
Sexual Quality of Life-Female Questionnaire (SQOL-F)
Time frame: 1 day At the first interview, the Sexual Quality of Life-Female Questionnaire (SQOL-F) was administered to menopausal women in both groups as a pretest.
The scale consists of a total of 18 items, requiring responses regarding sexual problems in the last 4 weeks. This is a Likert-type scale with six response options. For item scoring from 0 to 5, the minimum and maximum possible scores on the scale are 0 and 90, respectively. For item scoring between 1 and 6, the minimum and maximum possible scores on the scale are 18 and 108, respectively. In this study, the scoring system between 1 and 6 was used. Higher scores on the scale indicate a good quality of sexual life.
Sexual Quality of Life-Female Questionnaire (SQOL-F)
Time frame: Four week after the first interview, the Sexual Quality of Life-Female Questionnaire (SQOL-F) was applied to all menopausal women in all two groups as a posttest
The scale consists of a total of 18 items, requiring responses regarding sexual problems in the last 4 weeks. This is a Likert-type scale with six response options. For item scoring from 0 to 5, the minimum and maximum possible scores on the scale are 0 and 90, respectively. For item scoring between 1 and 6, the minimum and maximum possible scores on the scale are 18 and 108, respectively. In this study, the scoring system between 1 and 6 was used. Higher scores on the scale indicate a good quality of sexual life.
Sexual Self-Efficacy Scale (SSES)
Time frame: 1 day At the first interview, the Sexual Self-Efficacy Scale (SSES) was administered to menopausal women in both groups as a pretest.
The SSES was developed by Humphreys and Kennett (2010), and its Turkish validity and reliability study was conducted by Çelik (2012). The 8-point Likert scale consists of 5 items, scoring from 1 = Strongly Disagree to 8 = Strongly Agree and representing a single factor. The self-reporting scale was developed to determine individuals' sexual self-efficacy, where total scores are obtained by reverse coding items 3 and 4. Higher scores on the scale indicate higher levels of sexual self-efficacy. Total scale score ranges between 5 and 40.The Cronbach's alpha coefficient for the scale is 0.71. In this study, the Cronbach's alpha reliability coefficient was found as 0.93 for the experimental group and 0.90 for the control group.
Sexual Self-Efficacy Scale (SSES)
Time frame: Four week after the first interview, the Sexual Self-Efficacy Scale (SSES) was applied to all menopausal women in all two groups as a posttest
The SSES was developed by Humphreys and Kennett (2010), and its Turkish validity and reliability study was conducted by Çelik (2012). The 8-point Likert scale consists of 5 items, scoring from 1 = Strongly Disagree to 8 = Strongly Agree and representing a single factor. The self-reporting scale was developed to determine individuals' sexual self-efficacy, where total scores are obtained by reverse coding items 3 and 4. Higher scores on the scale indicate higher levels of sexual self-efficacy. Total scale score ranges between 5 and 40.The Cronbach's alpha coefficient for the scale is 0.71. In this study, the Cronbach's alpha reliability coefficient was found as 0.93 for the experimental group and 0.90 for the control group.
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 29 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Sexual Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
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.
Hülya KAMALAK, Phd principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group (motivational interview) in people with Sexual Dysfunction, run by Hülya KAMALAK 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 6 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 29 Mar 2024. 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?
Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F) (time frame: 1 day At the first interview, the Arizona Sexual Experiences Scale - Female Version Survey (ASEX-F) was administered to menopausal women in both groups as a pretest.). The study lists 6 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 29 Mar 2024.