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

NCT02647840 | Completed

• 1 other identifier: 185519
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dysphonia

Keywords

dysphonia; voice therapy

Outcome Measures

Primary Outcomes (1)

• Voice Handicap Index 10

  Patient report questionnaire (Using OperavOx app)

  at initial and final assessment, before after therapy (approx 3 month interval)

Secondary Outcomes (1)

• Qualitative feedback

  after intervention, within 6 weeks of discharge

Other Outcomes (4)

• Patient rating of their own therapy goal

  at initial and final assessment, before and after therapy (approx 3 month interval)

• Perceptual Voice Rating

  at initial and final assessment, before and after therapy (approx 3 month interval)

• Maximum phonation time

  at initial and final assessment, before and after therapy (approx 3 month interval)

Study Arms (1)

Voice therapy

OTHER

All participants will receive voice therapy based on the Estill model. This is very similar to our usual intervention.

Behavioral: voice therapy

Interventions

voice therapy BEHAVIORAL

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.

Also known as: Estill voice model

Voice therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of muscle tension dysphonia or functional dysphonia

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Speech and Language Therapy Department, Royal Devon and Exeter NHS Foundation Trust (Wonford)

Exeter, Devon, United Kingdom

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Malcolm P Hilton, MD

  Royal Devon and Exeter NHS Trust

  STUDY CHAIR

• Marianne E Bos-Clark, MSc

  Royal Devon and Exter NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 6, 2016
• Study Start: May 1, 2016
• Primary Completion: March 28, 2017
• Study Completion: April 27, 2017
• Last Updated: August 21, 2019

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)