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

NCT03378609 | Completed

• 1 other identifier: JB_2016-01511
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  one day

Study Arms (1)

Vocal Fatigue Index (VFI)

OTHER

Standardized Questionnaire assessing vocal fatigue

Other: Vocal Fatigue Index (VFI)

Interventions

Vocal Fatigue Index (VFI) OTHER

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

Also known as: Voice Handicap Index (VHI9i), Vocal Tract Discomfort Scale (VTD)

Vocal Fatigue Index (VFI)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

ORL Klinik

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: December 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: March 8, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)