Trial document





This trial has been registered retrospectively.
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  DRKS00005938

Trial Description

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Title

Multicenter study on the effectiveness of voice therapy

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Trial Acronym

Eff_Sti

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URL of the Trial

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Brief Summary in Lay Language

The project deals with evidence-based voice therapy. A cross-method-therapeutic approach in voice therapy in Germany is tested on its effektiveness - which has not been adressed in further research.
The outcome of 138 patients with voice disorders, who are involved a voice therapy program all over Germany were analyzed. Data from acustic analyses and self-questionaires are gathered. 22 Therapists were involved. Points of Data: 2x before Intevention, after ten Interventionens,after 20 Interventions. Follow up: until 1,5 Years after therapy (n=57)

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Brief Summary in Scientific Language

The study is carried out at a total of 22 therapists in nine states in Germany. The aim is to collect outcome data in voice therapy. The data consists of acoustic, perceptual and subjective measurement parameters. There is an overall of 138 patients with functional voice disorders and max. 20 sessions of voice therapy.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005938
  •   2014/07/17
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  •   yes
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Secondary IDs

  •   U1111-1158-4529 
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Health Condition or Problem studied

  •   R49 -  Voice disturbances
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Interventions/Observational Groups

  •   control: 30 persons without a voice disorder. Data from akustik und perzeptive analysis (Jitter, Shimmer, F0, GRBAS) gathered by recording voices by reading a text and talking about a free choosable theme. There were tree points of data gathering. A Coeffizient of Variability was calculated.
  •   Intervention: 138 patients with non organic functional voice disorders without hearing loss. Self assessments: voice handycap index (VHI), the voice-profile for occupational voice users (SPBS), Vocal tract discomfort scale (VTD). There was a subgroup (n=42) with added acustical and perceptive analysis (Jitter, shimmer, GRBAS, F0) in different conditions (Reading a text, talking), Functional analysis: Maximum Phonation Time (MPT), s/z-ratio. An other subgroup of n=57 took part in a follow up up to 1,5 years after end of therapy.

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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Outcome in voice parameters of the first, 10th. and 20th lession of voice therapy and up to 1,5 years after end of therapy (follow up: longterm effects).
Self assessments: voice handycap index (VHI), the voice-profile for occupational voice users (SPBS), Vocal tract discomfort scale (VTD). There was a subgroup (n=42) with added acustical and perceptive analysis (Jitter, shimmer, GRBAS, F0) in different conditions (Reading a text, talking), Functional analysis: Maximum Phonation Time (MPT), s/z-ratio.

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Secondary Outcome

The length of therapy until a regular voice quality is reached will be calculated by comparison of the outcome after 10 lessions of voice therapy to 20 lessions. Documentation of content of therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/07/01
  •   170
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Intervention gruop: functional voice disorders
control group: no voice disorder

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Exclusion Criteria

organic voice disorder, hearing loss, comorbid deseases, vegetative-degenarative deseases (e. g. Morbus Parcinson).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • HAWK-Hochschule Hildesheim/Holzminden/Göttingen
    • Ms.  Prof. Dr.  Ulla  Beushausen 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
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    • HAWK-Hochschule Hildesheim/Holzminden/Göttingen
    • Ms.  Prof. Dr.  Ulla  Beushausen 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
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    • HAWK-Hochschule Hildesheim/Holzminden/Göttingen
    • Ms.  Prof. Dr.  Ulla  Beushausen 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
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Sources of Monetary or Material Support

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    • HAWK Hildesheim/holzminden/Göttingen
    • Ms.  Prof. Dr.  Ulla  Beushausen 
    • Goschentor 1
    • 31134   Hildesheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.