Multiple Sclerosis Intimacy and Sexuality Questionnaire

May 11, 2022 updated by: hanife dogan, Bozok University

The Multiple Sclerosis Intimacy and Sexuality Questionnaire-15 (MSISQ-15): Validation of the Turkish Version in Patients With Multiple Sclerosis

Aims: This study aimed to psychometrically evaluate the Turkish version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-15) in women with MS.

Methods: The study included 130 women with MS. The Turkish linguistic validation process of the original English MSISQ-15 was performed according to standardized guidelines. Reliability analysis was evaluated with test-retest analysis and intra-class correlation (ICC). Internal consistency between the items was analyzed using the Cronbach's alpha coefficient. Item analysis results were used to assess the contribution of the items to the scale. In evaluating the validity of the scale, the relationship between the MSISQ and the Female Sexual Function Index (FSFI), the Multiple Sclerosis Quality of Life Questionnaire-54 (MSQOL-54), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PSIQ-12) was investigated. Psychometric properties were analyzed using internal consistency, test-rest reliability, construct validity, and floor-ceiling effect.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Yozgat, Turkey, 66000
        • Yozgat Bozok University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Multiple Sclerosis women

Description

Inclusion Criteria:

  • Women over the age of 18 who were literate,
  • who did not have any mental problems preventing cooperation and understanding,
  • who were diagnosed with MS

Exclusion Criteria:

  • Having pelvic organ prolapse stage 2 or more;
  • having a history of relapse in the past 30 days;
  • experiencing loss of balance or gait disturbance caused by a condition other than MS;
  • being pregnant; having a history of gynecological, urological and/or neurological surgery;
  • having a history of cesarean or vaginal birth in the past six months;
  • being sexually inactive; and, having urinary tract infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: day 1
Multiple Sclerosis Intimacy and Sexuality Scale is a 15-item self-report measure that assesses the impact of MS symptoms on sexual activity and satisfaction over the past 6 months.Higher scores indicate greater sexual problems.
day 1
Questionnaire
Time Frame: day 1
Female Sexual Function Index is a 19-item scale that evaluates the sexual functions of female patients. The questionnaire consists of 6 separate subdimensions: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate better sexual function.
day 1
Questionnaire
Time Frame: day 1
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire is an instrument that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. Increasing scores indicate better sexual function.
day 1
Questionnaire
Time Frame: day 1
Global Pelvic Floor Bother Questionnaire is used to evaluate the presence and severity of the most common clinical problems caused by the pelvic floor dysfunction, namely, stress urinary incontinence, frequent and sudden urination sensation, urge incontinence, voiding difficulty, pelvic organ prolapse, obstructive defecation, fecal incontinence, and dyspareunia. A high score indicates more pelvic floor symptom complaints.
day 1
Questionnaire
Time Frame: day 1
Multiple Sclerosis Quality of Life Questionnaire-54 is used to evaluate the quality of life of patients with MS. Higher scores indicate better quality of life.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 12, 2021

Primary Completion (ACTUAL)

December 10, 2021

Study Completion (ACTUAL)

March 10, 2022

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (ACTUAL)

May 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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