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Prevalidation of the First German Version of the Vocal Fatigue Index (VFI) (VFI)

Primary Purpose

Vocal Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Vocal Fatigue Index (VFI)
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vocal Fatigue

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18 years
  • voice disorder (all etiologies)

Exclusion Criteria:

  • age < 18 Jahre
  • current voice therapy
  • psychological disease
  • botox injection in the Larynx
  • inability to independently fill out the questionnaire

Sites / Locations

  • ORL KlinikRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Vocal Fatigue Index (VFI)

Arm Description

Standardized Questionnaire assessing vocal fatigue

Outcomes

Primary Outcome Measures

Validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
testing validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD

Secondary Outcome Measures

Reliability of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
testing reliability of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD

Full Information

First Posted
December 14, 2017
Last Updated
May 23, 2023
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03378609
Brief Title
Prevalidation of the First German Version of the Vocal Fatigue Index (VFI)
Acronym
VFI
Official Title
Prevalidation of the First German Version of the Vocal Fatigue Index (VFI)"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vocal fatigue has been described as a common complaint in patients with voice disorders, however to date there is no standardized questionnaire in german language to assess specific symptoms. Main aim of this study is to assess the validity of the first german version of the Vocal Fatigue Index (VFI), and english questionnaire developed for voice patients to assess vocal fatigue. In this study patients with voice disorders will receive the patient based questionnaires "Vocal Fatigue Index (VFI)", "Voice Handicap Index 9 international (VHI 9i)" and "Vocal Tract Discomfort Scale (VTD)", the study information and consent letter together with the standard invitation letter to a voice assessment at the Department for Phoniatrics and Speech Pathology University Hospital Zurich. Data of 93 consecutive volunteering patients will be collected. Furthermore a retest using the VFI will be conducted after 1 week with 10 volunteers. Thereafter construct validity of the VFI as compared to the established voice symptom questionnaires VHI 9i and VTD will be investigated. Further test-retest reliability will be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Fatigue

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vocal Fatigue Index (VFI)
Arm Type
Other
Arm Description
Standardized Questionnaire assessing vocal fatigue
Intervention Type
Other
Intervention Name(s)
Vocal Fatigue Index (VFI)
Other Intervention Name(s)
Voice Handicap Index (VHI9i), Vocal Tract Discomfort Scale (VTD)
Intervention Description
collection of 190 consecutive data sets, participants give separate consent for participating a retest or an interview, retest will be realised with the 10 following volunteers
Primary Outcome Measure Information:
Title
Validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
Description
testing validity of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
Time Frame
one day
Secondary Outcome Measure Information:
Title
Reliability of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
Description
testing reliability of the first German version ot the Vocal Fatigue Index (VFI) compared to the VHI9i and VTD
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 years voice disorder (all etiologies) Exclusion Criteria: age < 18 Jahre current voice therapy psychological disease botox injection in the Larynx inability to independently fill out the questionnaire
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joerg Bohlender, KD Dr.
Phone
044 255 58 30
Email
joerg.bohlender@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Meike Brockmann-Bauser, Dr. MSc
Phone
044 255 58 30
Email
meike.brockmann-bauser@usz.ch
Facility Information:
Facility Name
ORL Klinik
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meike Brockmann
Email
meike.brockmann-bauser@usz.ch
First Name & Middle Initial & Last Name & Degree
Jörg Bohlender
Email
joerg.bohlender@usz.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevalidation of the First German Version of the Vocal Fatigue Index (VFI)

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