Clinical trial NCT02409758: Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises
Official title: The Effectiveness of the Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises Method in Behavioral Dysphonia: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dysphonia
Keywords: Voice disorders
Hoarseness
Therapy
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of the Comprehensive Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia.

Detailed description: Introduction: Voice therapy is the best indication for the most voice disorders, with a strong degree of recommendation based on systematic reviews and randomized clinical trials, with a predominance of benefit over risk. Some speech therapy techniques are specific, others are organized principles or with eclectic approaches, that use a combination of strategies. So far, few studies have tested the effectiveness of treatment for dysphonia due to time spent, safety and improved quality of life more comprehensive as they are made in clinical. Objective: To evaluate the effectiveness and safety of the Comprehensive Voice Rehabilitation Program compared with Vocal Function Exercises in behavioral dysphonia. Methods: 106 professional of voice with dysphonia behavior, between 18 and 50 years old and vocal complaints for more than six months. These professionals have been evaluated by an otolaryngologist, randomized to participate of Vocal Function Exercises arm or Comprehensive Voice Rehabilitation Program arm. Both arms were follow for six sessions with speech therapists and reassessed when finish the period and after one month. The primary outcomes assessed are: reduction of VHI score, improved voice quality in the CAPE-V and improves the larynx condition. Conclusions: The Comprehensive Voice Program has an eclectic approach and follows the philosophy of what is practiced in clinics in Brazil. We believe this program can demonstrate the power of voice therapy effectiveness more organized to solve problems, with shorter duration of treatment, benefit patient health and funding agencies such as Unified Public Health System (SUS) and health insurance.

Eligibility criteria: Inclusion Criteria:

* voice professionals with behavioral dysphonia, with or without larynx lesions, with otorhinolaryngologist's indication;
* over 6 months with vocal complain;
* 3 or more signs and symptoms in the questionary.

Exclusion Criteria:

* Other kind of vocal disorder, speech or language disorder, malignant lesions, hormonal disturbances related by the patient, laryngeal papilloma, etc.
* Singers;
* neurological problems;
* acute larynx problem.

Primary outcomes:
measure: Improvement of the vocal quality (assessed by two self assessment questionnaires)
timeFrame: First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.
Secondary outcomes:
measure: Perceptual auditory analysis (assessed by 3 senior SLP)
timeFrame: First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.
measure: Improvement of larynx (evaluation by blind assessor)
timeFrame: First assesment: in the beggining of the treatment; 2nd assesment: after 6 weeks of treatment; 3rd assesment: a month after the end of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Vanessa P Vieira, PhD
role: STUDY_CHAIR
References:
citation: Ziegler A, Gillespie AI, Abbott KV. Behavioral treatment of voice disorders in teachers. Folia Phoniatr Logop. 2010;62(1-2):9-23. doi: 10.1159/000239059. Epub 2010 Jan 8.
citation: MacKenzie K, Millar A, Wilson JA, Sellars C, Deary IJ. Is voice therapy an effective treatment for dysphonia? A randomised controlled trial. BMJ. 2001 Sep 22;323(7314):658-61. doi: 10.1136/bmj.323.7314.658.
citation: Niebudek-Bogusz E, Sznurowska-Przygocka B, Fiszer M, Kotylo P, Sinkiewicz A, Modrzewska M, Sliwinska-Kowalska M. The effectiveness of voice therapy for teachers with dysphonia. Folia Phoniatr Logop. 2008;60(3):134-41. doi: 10.1159/000120290. Epub 2008 Mar 12.