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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06337058
Other study ID # KSUHULYAKAMALAK001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date December 15, 2022

Study information

Verified date March 2024
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date December 15, 2022
Est. primary completion date June 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - Having any diagnosed psychiatric illness, - Having entered menopause surgically, - Being on hormone replacement therapy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Turkey Kahramanmaras Sutçu Imam University Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Hülya KAMALAK

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
Primary 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. 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
Primary 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. 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.
Primary 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. 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
Primary 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. 1 day At the first interview, the Sexual Self-Efficacy Scale (SSES) was administered to menopausal women in both groups as a pretest.
Primary 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. 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
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