|- candidate number||10445|
|- NTR Number||NTR3123|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-okt-2011|
|- Secondary IDs||1423/11 |
|- Public Title||Effects of Two Interventions for Prevention of Voice Disorders in Teachers: Randomized Clinical Trial.|
|- Scientific Title||Effects of Two Interventions for Prevention of Voice Disorders in Teachers: Randomized Clinical Trial.|
|- hypothesis||The vocal massage therapy can be a primary intervention in preventing voice disorders in teachers when compared to vocal exercise.|
|- Healt Condition(s) or Problem(s) studied||Proffesional voice|
|- Inclusion criteria||1. Develop activity faculty at higher level;|
2. Have workload of 40 hours weekly;
3. Have vocal complaint;
4. Sign the Instrument of Consent.
|- Exclusion criteria||Will be excluded characters who are performing some vocal treatment, either for treatment or voice enhancement.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||21-nov-2011|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||40|
|- Interventions||Will be two interventions in which subjects are randomly assigned to groups, through a computer program. One group will receive voice training traditional and the other group, technique of vocal massage. In total, eight meetings will be held, of whom six will be intervention, and the first and last are designed to evaluate the voice quality and application of a subjective evaluation protocol of the voice.
In voice training traditional will be dealt two methods used in voice therapy: Sounds facilitators and speech method. The techniques selected of method of facilitators sounds are: Vibrants and nasal. These two modes will be used in sustained and modulated emissions, and associated with vowels.
In the vocal massage workshop, massage will be held in the shoulder girdle and in laryngeal muscles. The massage technique works directly in the neck muscles, this technique will be used with touch movements, press, and stretching in combination with the use of massager, hammers of rubber and massage balls. For the laryngeal muscle are going to do descending digital motion and lateral displacement of the skeleton of the larynx and circular motions and press lightly on the thyroid membrane.
|- Primary outcome||Perception of a voice problem with respect to activity limitations and participation restrictions.|
Timepoint: 8 weeks.
|- Secondary outcome||1. Overall assessment of the degree of dysphonia.|
Timepoints: 8 weeks;
2. Jitter: Variability of fundamental frequency in the short term.
Timepoints: 8 Weeks;
3. Shimer : Variability of the sound wave amplitude in the short term.
Time points: 8 weeks;
4. The glottal noise energy.
Timepoints: 8 weeks.
|- Timepoints||8 Weeks.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Tanise Cristaldo Anhaia|
|- CONTACT for SCIENTIFIC QUERIES|| Tanise Cristaldo Anhaia|
|- Sponsor/Initiator ||Universidade Federal de Ciências da Saúde de Porto Alegre|
(Source(s) of Monetary or Material Support)
|Universidade Federal de Ciências da Saúde de Porto Alegre|
|- Brief summary||Effects of Two Interventions for Prevention of Voice Disorders in Teachers: Randomized Clinical Trial.
Considered a relevant factor for the process of human socialization, the voice has an impact on quality of life of individuals, especially those who make use of it in speaking and / or singing professionally. Teachers are professional voice users who are more predisposed to develop voice disorders. Given the social and economic damage caused by the voice disorder in teachers, different approaches, for example, methods of massage have been used to prevent and reduce excessive laryngeal muscle tension. However, according to the literature, more evidence is needed, through research of the vocal effects of massage therapy compared to other interventions.
To compare the effects of massage therapy and of traditional vocal training in teachers.
This is a pilot study, a randomized clinical trial to be held at the Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA).The sample universe consists of UFCSPA teachers. There will be two interventions in which subjects are randomly assigned to groups. One group will receive traditional voice training and the other group will have intervention by vocal massage technique. In total, eight meetings will be held, of which six will be interventions, the first and last sessions are designed to evaluate the voice quality and application of a vocal self-assessment protocol. The variables evaluated in this study are self-assessment and vocal quality. The Protocol Profile and Vocal Activities and Participation (Ricarte, Behlau andGasparini, 2006), will be used to measure the self-assessment of the outcome of interventions. To evaluate the voice quality will be used GRBASI Japanese scale(Hirano, 1981), and the acoustic parameters glottal noise energy (ERG), shimmer and jitter. In the end, a statistical analysis is going to be performed using the statistical software Epi Info and Excel. For variables with normal distribution, parametric tests are going to be performed followed by mean and standard deviation otherwise will be used nonparametric tests.
|- Main changes (audit trail)|
|- RECORD||27-okt-2011 - 10-nov-2011|