A Proof-of-concept Study of the Complete Vocal Technique (CVT), a Pedagogic Technique Used for Performers, in Improving the Voice and Vocal Function in Patients With Muscle Tension Dysphonia Using Telehealth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Voice Handicap Index (VHI)
研究概览
简要总结
This proof-of-concept study is designed to evaluate whether a pedagogic technique used to help performers, known as the Complete Vocal Technique (CVT), can be used to help patients with a type of voice disorder known as Muscle Tension Dysphonia (MTD). MTD is responsible for up to 40% of patients presenting with voice and throat complaints. MTD is due to inefficient or ineffective voice production resulting from an imbalance in the control of the breathing mechanism, and uncontrolled constriction of the muscles in the larynx (voice box) or vocal tract (throat space above the vocal cords). Standard treatment is Voice Therapy delivered by a specialist Speech Therapist (SLT-V) often using a video link (telepractice aka telehealth). CVT is widely used in Europe by singers and vocal coaches. Practitioners (CVT- Ps) undergo a three-year accredited training programme, and the systematic and structured approach helps healthy singers and other performers optimise the function of the voice to produce any sound required. It also helps if the performer has vocal problems, which are also mainly due to uncontrolled throat constrictions.
The purpose of this pilot study is to see if the CVT voice therapy approach (CVT-VT) can help, and offers advantages, to standard SLT-V methods in the treatment of patients with MTD. Ten adult patients will be recruited from the Voice clinic at Nottingham University Hospital. Participants will have a multidimensional assessment using questionnaires, and voice recordings and then receive up to 6 video sessions of CVT-VT delivered using a video link by a CVT-P. The participants will then be reviewed back in clinic at 8 weeks and be reassessed, using further questionnaires and analysis of the voice pre- and post-therapy recordings, to evaluate the outcome of this treatment approach. Qualitative methodology will determine whether CVT-VT offers any therapeutic advantages to existing SLT-VT treatment methods.
详细描述
Voice problems (dysphonia) affect one in 13 adults annually, causes a major impact on quality of life and livelihood and is a substantial healthcare burden. It is more common in women and in those with vocally demanding professions and the elderly. Forty percent of patients referred for assessment of a voice problem have Muscle Tension Dysphonia (MTD) as a cause brought on by an imbalance of breathing mechanism and/or uncontrolled tightness of the muscles of the voice box or throat. The main symptoms are hoarseness, abnormal pitch or loudness, variability in quality or control of the voice, throat discomfort or difficulty in using the voice such as being able to use a louder voice when needed, or a voice that fatigues with use with a consequent impact on quality of life. Traditionally there are six described recognisable patterns of MTD based on the presenting symptoms, voice quality and on appearance of the larynx (voice box) on examination with a video camera. Three types (MTD patterns I-III) are more related to ineffective voice use, also known as 'voice abuse' or 'voice misuse', while the other three types (MTD patterns IV-VI) have a predominantly psychological basis.
In the United Kingdom (UK), patients with persistent or unexplained hoarseness who are over the age of 45 are referred under the two-week wait (2WW) cancer referral process. In other cases, referral to an Ear, Nose and Throat (ENT) benign voice service is usually considered if the dysphonia persists for more than six weeks, if it has not improved with simple measures such as voice rest, reducing irritation to the vocal cords and drinking plenty of fluids (known as vocal hygiene advice) or it is impacting significantly on the patient's work or social life. In practice patients with MTD may come through both the 2WW and benign voice pathways.
A diagnosis of MTD is made by an ENT surgeon and/or Speech & Language Therapist who has specialised in voice disorders (SLT-V) based on the history of the vocal complaint and by excluding an organic cause by examination of the patient's voice box (larynx) with a small flexible video camera passed through the nose. Treatment is with voice therapy given by a SLT-V. Voice therapy consists of two main types: Indirect Voice Therapy and Direct Voice Therapy and is guided by advice from professional organisations such as Royal College of Speech and Language Therapists Clinical Guidelines and the American Speech-Language-Hearing Association (ASHA) Clinical Practice Guideline: hoarseness (dysphonia). Indirect therapy consists of education, information, vocal hygiene, and stress management to encourage behavioural change. Direct therapy consists of establishing healthy voice production by rebalancing the three subsystems of voice production namely breathing (respiration), voice production (phonation) and more efficient use of resonance.
The aim of voice therapy is generally to (a) return the patient's voice to normal or as best as possible within the patient's anatomic and physiologic capabilities and (b) to satisfy the patient's occupational, social and emotional vocal needs and (c) promote habit changes that will ensure voice improvement will be maintained. Therapeutic goals should be specific and determined by the patient prior to therapy to empower the patient in shared decision making with the aim of improving motivation and compliance. In addition, the aim should be maximum improvement in the minimum time.
MTD is a mixed group of conditions with different patterns of presentation and numerous patient specific factors. In addition, Direct Voice Therapy is not just one treatment method and many SLT-Vs use a hierarchical approach, which focuses in the early stages on postural and relaxation techniques, followed by breathing exercises, voicing and resonance work with final consolidation and review. The techniques applied by a SLT-V are also dependent on abnormal findings on clinical examination the training and experience of the therapist and the response and engagement of the patient. Although having a large variety of techniques that can be used which can be tailored to the individual, Voice therapy has been portrayed as a "black box" and many recognised treatment regimens overlap in the treatment aims and therapeutic goals. This makes it difficult to determine why patients improve, which therapy tasks are most beneficial and for how long the tasks should be continued.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary Muscle Tension Dysphonia (MTD) based on history and laryngoscopic assessment (Type (I-III) MTD pattern) through joint assessment by a SLT-V and laryngologist
- •Current voice problems, persistent for greater than 2 months
- •Severity of disorder a) Voice Handicap Index (VHI) ≥ 30 and b) patient wants therapy
- •Patient willingness to undergo treatment
- •Consent to participate in study protocol
排除标准
- •Organic vocal pathology 1) Structural/neoplastic disorders (e.g. carcinoma, cyst, polyp, papilloma, Reinke's oedema); 2) neurological disorders (e.g. vocal cord palsy, paresis, spasmodic dysphonia); 3) inflammation (e.g. infection, reflux (RFS >7) or significant relevant systemic disease (e.g. severe Chronic Obstructive Pulmonary Disease) or need for surgery
- •Significant psychological issues identified during initial assessment (with option to withdraw if discovered during the treatment periods and agreed by both patient and Therapist)
- •MTD pattern (IV-VI) compatible with significant primary psychological aetiology on laryngoscopy
- •Transgender voice issues
- •Previously incompletely treated dysphonia, neurological disease, or upper aerodigestive tract malignancy Had previous Voice Therapy (VT) or CVT training or pharmacological treatment for their voice problem - (other than proton pump inhibitors or an alginate recommended for disorders of laryngopharyngeal reflux-related symptoms)
- •A hearing impairment that would prohibit or impact on telepractice treatment
- •Significant concomitant health problems affecting voice
- •Not have or be able to use a computer with video link at home or in hospital even with support
研究组 & 干预措施
Complete Vocal Technique Voice Therapy
Up to six 45 minute sessions delivered by a CVT Practitioner using a video link within an eight week therapy period
干预措施: Complete Vocal Technique Voice Therapy (Behavioral)
结局指标
主要结局
Voice Handicap Index (VHI)
时间窗: Eight weeks
Questionnaire to evaluate patient's self-reported perception of the impact of his or her voice disorder
次要结局
- CVT Practitioner Experience Feedback Form: Achievement of specific goals(Eight weeks)
- Psychoacoustic evaluation of the recorded voice samples(Eight weeks)
- CVT Practitioner Experience Feedback Form: Experience of therapy(Eight weeks)
- Vocal tract discomfort scale questionnaire(Eight weeks)
- Patient Experience Feedback Form: Achievement of specific goals(Eight weeks)
- Patient Experience Feedback Form: Experience of therapy(Eight weeks)
- Feedback form: use of the video link(Eight weeks)
- Acoustic and Electroglottographic (EGG) voice analysis pre and pots-therapy(Eight weeks)
- The Maximum Phonation Time (MPT)(Eight weeks)
