Authors
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Faculdade de Medicina da Universidade Federal de Minas Gerais -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2026
INTERVENTION: This is a parallel, two‐arm, single‐blind, randomized controlled clinical trial to be conducted with higher education professors at a private university center located in the municipality of Formiga, Minas Gerais, Brazil, and divided into two stages. The first stage will consist of an analytical cross‐sectional observational study aimed at characterizing the participants’ vocal conditions and factors associated with professional voice use. The second stage will be conducted as a randomized controlled clinical trial, in which eligible participants will be randomly allocated to two groups through a draw conducted by an independent researcher using an electronic random number generator. The allocation sequence will be kept in opaque, numbered, and sealed envelopes to ensure allocation concealment. A total of 40 professors are expected to participate, with 20 participants in Group 1 and 20 participants in Group 2. Group 1 will undergo the Integral Vocal Rehabilitation Program (PIRV), while Group 2 will undergo the Integral Vocal Rehabilitation Program combined with the use of the Shaker Classic® therapeutic device. The intervention will last si Xweeks. The Integral Vocal Rehabilitation Program will consist of a series of exercises based on principles of motor learning and will be performed by both groups, with the difference that Group 2 will additionally use the Shaker Classic® therapeutic device. From the third week of the intervention onward, both groups will receive instructions on vocal warm‐up exercises. The weekly frequency and duration of each intervention session will be defined according to the adopted intervention protocol. The study will be single‐blind, with the examiners responsible for assessing perceptual‐auditory and laryngeal outcomes blinded to the participants’ group allocation and intervention procedures. Before and after the six‐week intervention, participants will undergo perceptual‐auditory voice assessment, acoustic voice analysis, otorhinolaryngological evaluation, and administration of the questionnaires included in the study. For the acoustic assessment, sustained /a/ vowel productions, counting from 1 to 20, and reading of a standardized text will be collected, allowing the analysis of fundamental frequency, jitter, shimmer, harmonic‐to‐noise ratio, cepstral measures, and multiparametric measures of vocal quality. Otorhinolaryngological evaluation will be performed before and after the intervention, with laryngeal images stored for subsequent analysis. Perceptual‐auditory and laryngeal outcomes will be assessed by independent examiners who are blinded to the procedures performed by the participants. Voices and laryngeal images will be identified using numerical codes and presented to the evaluators in a coded format to reduce potential assessment bias. Three speech‐language pathologists with at least five years of experience in the field of voice will participate in the perceptual‐auditory assessment, while two otorhinolaryngologists with at least five years of experience in laryngeal examinations will perform the otorh CONDITION: H02.010.750 Speech; Voice; Phonation ; Speech‐Language Pathology PRIMARY OUTCOME: An improvement in vocal quality is expected after the intervention, assessed through perceptual‐auditory voice analysis, based on a reduction in the scores for the overall degree of vocal deviation between the pre‐ and post‐intervention measurements, considering the comparison between the intervention groups. SECONDARY OUTCOME: A reduction in vocal symptoms is expected after the intervention, assessed using the Vocal Symptoms Scale (VSS), based on a reduction in the total score between the pre‐ and post‐intervention measurements, considering the comparison between the groups. The total VSS score will be used as the parameter, with higher scores indicating greater vocal symptomatology, and a cutoff score of 16 points will be used as an additional parameter for characterizing the risk of dysphonia. An improvement in acoustic voice parameters is expected after the intervention, assessed through computerized acoustic voice analysis, based on changes in the values of fundamental frequency (F0), jitter, shimmer, harmonic‐to‐noise ratio (HNR), cepstral peak prominence (CPP/CPPS), Acoustic Voice Quality Inde X(AVQI), and Acoustic Breathiness Inde X(ABI) between the pre‐ and post‐intervention measurements, considering the comparison between the groups. INCLUSION CRITERIA: Actively teaching in the classroom; indicators of vocal risk according to the Voice Disorder Screening Inde Xor Voice Symptom Scale screening protocols; aged between 18 and 59 years; and not undergoing speech‐language therapy for voice
Epistemonikos ID: 5d250efd0d7c196de261fad4d54f7e3568adbd22
First added on: Oct 08, 2026