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

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

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.

Study Overview

• Status: Completed
• Conditions: Vocal Fatigue
• Intervention / Treatment: Other: Vocal Fatigue Index (VFI)

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • ORL Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vocal Fatigue Index (VFI); Standardized Questionnaire assessing vocal fatigue	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; Other Names: Voice Handicap Index (VHI9i); Vocal Tract Discomfort Scale (VTD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: JB_2016-01511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No