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临床试验/NCT02647840
NCT02647840已完成不适用

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

Royal Devon and Exeter NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Voice Handicap Index 10

研究概览

简要总结

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.

详细描述

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 assessments that will be analysed using descriptive statistics. We will also use qualitative research design when we use post-intervention focus groups to evaluate participants' experiences.

The study design does not control bias as it is not controlled and participants are not blinded to the intervention. We will therefore not be able to make a judgment as to whether Estill based voice therapy is effective in treating functional dysphonia in this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of muscle tension dysphonia or functional dysphonia

排除标准

  • 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

研究组 & 干预措施

Voice therapy

Other

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

干预措施: voice therapy (Behavioral)

结局指标

主要结局

Voice Handicap Index 10

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

Patient report questionnaire (Using OperavOx app)

次要结局

  • Qualitative feedback(after intervention, within 6 weeks of discharge)

研究者

发起方
Royal Devon and Exeter NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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