Clinical Trial: The Effects of Voice Therapy Based on the Estill Voice Model: a Feasibility Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effects of Voice Therapy Based on the Estill Voice Model: a Feasibility Study

Brief Summary:

This study wants to investigate treatment for patients with common voice disorders where no surgical or medical treatment is needed. A voice disorder is when your voice is croaky, hoarse or when you lose it altogether. This can be a serious problem for people as it stops them from participating in their normal life (for example in their jobs, hobbies, family and wider social life).

This study will look at our most commonly used method of treatment for voice problems. This method is based on physical exercises which work on the muscles which produce the voice. This voice work was originally developed by Jo Estill, a singer and scientist, and is widely used in voice coaching. Though many Speech and Language Therapists (SLTs) provide voice therapy based on the Estill model, there is no clinical evidence to support its use.

The aim of this study is to test the design for a larger research study into the effects of voice therapy based on Estill model of voice. We want to find out if our tests work and are easy to use, and to check that the study methods are right and would work on a larger scale. It is a feasibility study, and therefore allows us to test whether this study can be done. Another important part of this study is to involve patients in developing research. We want to find out what patients think about the treatment they receive, and about taking part in a study.

The way this study will work is that patients who have agreed to take part will have between four and six voice therapy appointments, just like they would if they were not part of the study. Voice test results from before and after treatment will be compared and carefully studied. After patients taking part in the study have finished their treatment, they will be asked about their experience of voice therapy,

Detailed Summary:

Aims and Objectives The overall aim of this study is to test the feasibility of a study into the effects of Estill based voice therapy for patients with functional dysphonia.

The objectives are:

To gather information that will help us design a larger study, specifically

  • how many participants can we expect to recruit
  • what is the rate of consent
  • what is the rate of attrition
  • how many therapy sessions do patients attend over what length of time (length episode of care & total therapy time in minutes) To test our outcome measures
  • is using OperaVOX on iPad for clinical outcome measurement useful for clinician and participant; is it quick, easy to use, and reliable?
  • what is the Standard Deviation (SD) for outcome measures so that we can estimate sample size for a further trial To describe therapy content in detail so that it can be replicated and meaningfully practised by participants
  • what advice sheets/ therapy instructions do we give To investigate participant experience
  • What is it like to have functional dysphonia
  • What is it like to have voice therapy
  • What is it like to take part in a study
  • Does the overall design work smoothly for participants
  • What worked well/ what could be better for participants Plan of investigation General research design This is a feasibility study using a mixed method research design. We will gain quantitative data from clinical voice asse
    Sponsor: Royal Devon and Exeter NHS Foundation Trust

    Current Primary Outcome: Voice Handicap Index 10 [ Time Frame: at initial and final assessment, before after therapy (approx 3 month interval) ]

    Patient report questionnaire (Using OperavOx app)


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Qualitative feedback [ Time Frame: after intervention, within 6 weeks of discharge ]

    Feedback form participants about the therapy and study given to independent researcher in small group interview after therapy


    Original Secondary Outcome: Same as current

    Information By: Royal Devon and Exeter NHS Foundation Trust

    Dates:
    Date Received: December 22, 2015
    Date Started: May 2016
    Date Completion: April 2017
    Last Updated: October 25, 2016
    Last Verified: October 2016