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Completed

NCT Number: NCT03378609

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.

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Key information

Conditions

Vocal Fatigue Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ORL Klinik

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Voice Handicap Index (VHI9i), Vocal Tract Discomfort Scale (VTD)

Primary outcomes

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

    Time frame: one day

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

Secondary outcomes

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

    Time frame: one day

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: VFI

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Dec 20, 2017
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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