NCT03101449

Brief Summary

This research aims to evaluate the effects of vocal conditioning through two semioccluded vocal tract exercises (SOVTE) in choir singers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

October 26, 2016

Last Update Submit

March 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Voice quality

    Improved singing voice quality standard demonstrated by the perceptual analysis of voice with CAPE- V, in which there is a decrease in score value pre and post intervention.

    3 months

Secondary Outcomes (6)

  • Mean fundamental frequency

    3 months

  • Jitter

    3 months

  • Shimmer

    3 months

  • Glottal to Noise Excitation (GNE)

    3 months

  • Profile vocal range

    3 months

  • +1 more secondary outcomes

Study Arms (3)

Group 1

EXPERIMENTAL

20 individuals of Coral UFCSPA without voice problems carry out the exercise with Finnish tube before choir practice once a week for a period of 14 weeks. The exercise will be carried out with blowing set to sound at regular frequency, with frequency variation and with the melody of "Happy Birthday"; each sequence will be held for 2 minutes with 1 minute interval between them.

Other: Finnish tube

Group 2

EXPERIMENTAL

20 individuals of Coral UFCSPA without voice problems carry out the exercise straw phonation before choir practice once a week for a period of 14 weeks. The exercise will be carried out with blowing set to sound at regular frequency, with frequency variation and with the melody of "Happy Birthday"; each sequence will be held for 2 minutes with 1 minute interval between them.

Other: Staw phonation

Group 3

NO INTERVENTION

10 individuals of Coral UFCSPA without voice problems. Untreated group.

Interventions

Practice the exercise with Finnish tube before choir practice once a week for a period of 14 weeks.

Group 1

Practice the exercise straw phonation before choir practice once a week for a period of 14 weeks.

Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signing of the Informed Consent (IC).

You may not qualify if:

  • voice disorders diagnosed by otolaryngologist physician;
  • smokers;
  • presence below 75% in the meetings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Science of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90.050-170, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dra. Mauriceia Cassol

Study Record Dates

First Submitted

October 26, 2016

First Posted

April 5, 2017

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

April 5, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations