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

NCT ID: NCT03378609

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2023-03-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vocal Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vocal Fatigue Index (VFI)

Standardized Questionnaire assessing vocal fatigue

Group Type OTHER

Vocal Fatigue Index (VFI)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Voice Handicap Index (VHI9i) Vocal Tract Discomfort Scale (VTD)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ORL Klinik

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JB_2016-01511

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fatigue and Hearing Loss.
NCT04875117 COMPLETED
Optimization of Music Compression
NCT02373228 COMPLETED NA