SF-QUALIVEEN Turkish Validity and Reliability Study

Multiple Sclerosis Clinical Trial

Official title:

SF-QUALIVEEN Turkish Cultural Adaptation, Validity and Reliability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483609
• Other study ID #: 2018/23-21
• Status: Completed
• Start date: July 30, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: June 2021
• Source: Istanbul Aydin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Urological dysfunction is common in patients with Multiple Sclerosis (MS) and its prevalence has been reported at a high rate of 32-97%. Bladder dysfunction is associated with a significant deterioration in the quality of life of people with MS. In chronic diseases such as MS, patients experiences need to be measured directly in order to have information about patients perceptions about the effect of the disease on quality of life. However, there are a small number of valid and reliable Turkish scales on this subject.SF-Qualiveen is a validated scale for patients with MS who assess the urinary-specific quality of life by examining the impact of a wide range of bladder problems.The aim of our study is to make the Turkish cultural adaptation, validity and reliability of the SF-Qualiveen scale.

Description:

The aim of this study is to reveal the Turkish cultural adaptation, validity and reliability of the SF-Qualiveen scale. In our study, Sf-Qualiveen and Urogenital Distress Inventory (UDI-6) scales will be used. Pre-testing will be done in 10 patients with multiple sclerosis.Then, the validity and reliability of the scale will be performed in 80 patients with multiple sclerosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. age 18-65;

2. definitive diagnosis of MS according to McDonald criteria;

3. ability to read and write in Turkish.

Exclusion Criteria:

1. acute attacks of MS (within 3 months);

2. cognitive impairment (Mini Mental test result 24 points and below);

3. any chronic disease other than MS;

4. active malignant tumors;

5. symptomatic urinary tract infections;

6. patients who changed treatment within the test-retest period.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Questionnaire administration pre test
After the translation and cultural adaptation of the SF-Qualiveen scale is completed, face-to-face pre-test will be performed on 10 patients with multiple sclerosis.
• Questionnaire administration validation and reliability
After the pre-test is completed, if necessary, arrangements will be made, and then the validity and reliability of SF-Qualiveen will be made in 80 individuals with Multiple Sclerosis.First of all, participants will be asked to complete two questionnaires (SF-Qualiveen and Urinary Distress Inventory). Two weeks after this assessment, they will be asked to respond to SF-Qualiveen again.

Locations

Country	Name	City	State
Turkey	Istanbul Üniversitesi-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Aydin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-Qualiveen score	To evaluate the impact of urological problems on quality of life	Baseline
Secondary	Urogenital Distress Inventory (UDI-6)	To assess problems caused by urinary symptoms	Baseline