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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
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphonia focused on measuring Voice disorders, Hoarseness, Therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 19, 2015
    Last Updated
    April 6, 2015
    Sponsor
    Federal University of São Paulo
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    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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