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

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ClinicalTrials.gov Identifier: NCT02647840
Recruitment Status : Unknown
Verified October 2016 by Royal Devon and Exeter NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : January 6, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

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, and of being in the study. Much of what will be done as part of the study is identical to what is normally done in treatment, however we will look in detail at all the tests, and we need permission from participants to use their test results and include their comments.

It is important to learn more about voice therapy and to improve voice therapy for patients with this type of voice problem. By finding out more what patients think about the treatment we provide, what tests to use, and about how best to run a research trial, we will be able to plan further research and hopefully be successful at a next large research grant application.


Condition or disease Intervention/treatment Phase
Functional Dysphonia Behavioral: voice therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Voice Therapy Based on the Estill Voice Model: a Feasibility Study
Study Start Date : May 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : April 2017

Arm Intervention/treatment
Voice therapy
All participants will receive voice therapy based on the Estill model. This is very similar to our usual intervention.
Behavioral: voice therapy
voice therapy based on Estill Voice Model The study will provide primarily direct intervention, i.e. working directly on the voice with voice exercises based on the Estill model of voice. This will be structured and hierarchical. Participants will work through the content one-to-one with the voice specialist SLT at their level and pace, to suit their specific vocal needs, again reflecting current clinical practice. Participants may need fewer or more than four sessions to gain the required skills. Should patients need more than six session of voice therapy to recover their voice fully, final assessment for the study purposes will be taken at session 6, and voice therapy will continue as required.
Other Name: Estill voice model




Primary Outcome Measures :
  1. Voice Handicap Index 10 [ Time Frame: at initial and final assessment, before after therapy (approx 3 month interval) ]
    Patient report questionnaire (Using OperavOx app)


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Patient rating of their own therapy goal [ Time Frame: at initial and final assessment, before and after therapy (approx 3 month interval) ]
    Participants define their own clinical goals and rate on 0-10 scale

  2. Perceptual Voice Rating [ Time Frame: at initial and final assessment, before and after therapy (approx 3 month interval) ]
    Perceptual rating of participant voice quality based on recorded samples, using GRBAS voice rating scale (Rough, Breathy, Strained parameter)

  3. Maximum phonation time [ Time Frame: at initial and final assessment, before and after therapy (approx 3 month interval) ]
    ability to sustain phonation (Using OperavOx app)

  4. Acoustic voice analysis [ Time Frame: at initial and final assessment, before and after therapy (approx 3 month interval) ]
    Acoustic analysis of voice sample: Jitter and Shimmer (Using OperavOx app)



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of muscle tension dysphonia or functional dysphonia

Exclusion Criteria:

  • hearing problems, cognitive difficulties such as memory loss, and significant co-morbidities such as uncontrolled reflux or previous radiotherapy for Head & Neck Cancer; significant psychological issues underlying the voice problem

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647840


Contacts
Contact: Marianne E Bos-Clark, MSc 01392-402489 ext 2489 mbos-clark@nhs.net
Contact: Claire L McAleer, BSc 01392-402489 ext 2489 c.mcaleer@nhs.net

Locations
United Kingdom
Speech and Language Therapy Department, Royal Devon and Exeter NHS Foundation Trust (Wonford) Recruiting
Exeter, Devon, United Kingdom
Contact: Marianne E Bos-Clark, MSc    01392-402489 ext 2489    mbos-clark@nhs.net   
Contact: Claire McAleer, BSc    01392-402489 ext 2489    m.caleer@nhs.net   
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Investigators
Study Chair: Malcolm P Hilton, MD Royal Devon and Exeter NHS Trust
Principal Investigator: Marianne E Bos-Clark, MSc Royal Devon and Exter NHS Trust

Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02647840     History of Changes
Other Study ID Numbers: 185519
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
dysphonia
voice therapy

Additional relevant MeSH terms:
Dysphonia
Hoarseness
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiration Disorders
Signs and Symptoms, Respiratory