Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises (Voicetherapy)
Primary Purpose
Dysphonia
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Voice therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dysphonia focused on measuring Voice disorders, Hoarseness, Therapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
VFE voice therapy
CVRP voice therapy
Arm Description
Voice therapy: Vocal Function Exercises applied during 6 weeks
Voice therapy: Comprehensive Voice Rehabilitation Program applied during 6 weeks
Outcomes
Primary Outcome Measures
Improvement of the vocal quality (assessed by two self assessment questionnaires)
The improvement was assessed by two questionnaires of self assessment vocal quality: Voice Related Quality of life questionnaire (VRQOL) and Voice Handicap Index (VHI) in the three different moments: pre therapy, post therapy and one month after therapy
Secondary Outcome Measures
Perceptual auditory analysis (assessed by 3 senior SLP)
The general grade of hoarseness was assessed blindness by 3 senior SLP in the three different moments: pre therapy, post therapy and one month after therapy. The 3 SLP assessors was blinded according to kind of therapy and moment of evaluation.
Improvement of larynx (evaluation by blind assessor)
Evaluation of the larynx by a senior otorhinolaryngologist in the three different moments: pre therapy, post therapy and one month after therapy. The otorhinolaryngologist assessor was blinded according to the kind of therapy and moment of evaluation.
Full Information
NCT ID
NCT02409758
First Posted
March 19, 2015
Last Updated
April 6, 2015
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02409758
Brief Title
Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises
Acronym
Voicetherapy
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia
Keywords
Voice disorders, Hoarseness, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VFE voice therapy
Arm Type
Active Comparator
Arm Description
Voice therapy: Vocal Function Exercises applied during 6 weeks
Arm Title
CVRP voice therapy
Arm Type
Experimental
Arm Description
Voice therapy: Comprehensive Voice Rehabilitation Program applied during 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy
Other Intervention Name(s)
Voice treatment, SLP
Intervention Description
Voice therapy applied during 6 weeks.
Primary Outcome Measure Information:
Title
Improvement of the vocal quality (assessed by two self assessment questionnaires)
Description
The improvement was assessed by two questionnaires of self assessment vocal quality: Voice Related Quality of life questionnaire (VRQOL) and Voice Handicap Index (VHI) in the three different moments: pre therapy, post therapy and one month after therapy
Time Frame
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 Outcome Measure Information:
Title
Perceptual auditory analysis (assessed by 3 senior SLP)
Description
The general grade of hoarseness was assessed blindness by 3 senior SLP in the three different moments: pre therapy, post therapy and one month after therapy. The 3 SLP assessors was blinded according to kind of therapy and moment of evaluation.
Time Frame
First assesment in the beggining of the treatment; 2nd assesment after 6 weeks of treatment; 3rd assesment a month after the end of treatment.
Title
Improvement of larynx (evaluation by blind assessor)
Description
Evaluation of the larynx by a senior otorhinolaryngologist in the three different moments: pre therapy, post therapy and one month after therapy. The otorhinolaryngologist assessor was blinded according to the kind of therapy and moment of evaluation.
Time Frame
First assesment: in the beggining of the treatment; 2nd assesment: after 6 weeks of treatment; 3rd assesment: a month after the end of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa P Vieira, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
20093840
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.
Results Reference
background
PubMed Identifier
11566828
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.
Results Reference
result
PubMed Identifier
18334848
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.
Results Reference
result
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Comprehensive Voice Rehabilitation Program Compared With Vocal Function Exercises
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