NCT06337058

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 1, 2024

Last Update Submit

March 28, 2024

Conditions

Keywords

Menopause PeriodMotivational InterviewSexual DysfunctionSexual Quality of LifeMidwifery

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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

  • 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.

  • 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

  • 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.

  • 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

Study Arms (2)

experimental group

EXPERIMENTAL

intervention group

Behavioral: Experimental group (motivational interview)

control group

NO INTERVENTION

control group

Interventions

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.

experimental group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Having any diagnosed psychiatric illness,
  • Having entered menopause surgically,
  • Being on hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutçu Imam University

Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hülya KAMALAK, Phd

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 29, 2024

Study Start

June 15, 2020

Primary Completion

June 15, 2021

Study Completion

December 15, 2022

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations