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

Vocal Fatigue Clinical Trial

— VFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378609
• Other study ID #: JB_2016-01511
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: March 8, 2023

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 8, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Vocal Fatigue

Intervention

Other:
• Vocal Fatigue Index (VFI)
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

Locations

Country	Name	City	State
Switzerland	ORL Klinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one day
Secondary	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	one day