Evaluation of Physiological and Vocal Parameters in Volunteers of Both Genders Submitted to an Anxiogenic Task

NCT ID: NCT01157273

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-07-31

Brief Summary

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Objective: To assess whether the anxiety caused by a task considered anxiogenic, Simulated Public Speaking (SPS) test, would change the responses of healthy individuals regarding physiological and vocal parameters. Method: The sample comprised 30 participants of both genders, 19-42 years old, with no history of psychiatric disorders. The score in the STAI-Trait enabled investigators to assign participants to two groups: LOW ANXIETY (LA) and HIGH ANXIETY (HA). The investigators evaluated physiological parameters (heart rate, skin conductance, temperature in the extremities, electromyogram of the frontal muscle and salivary cortisol) and vocal parameters (vocal self-evaluation, quality of life in voice and vocal symptoms and signs) BEFORE, DURING and AFTER the SPS.

Detailed Description

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Conditions

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Anxiety Communication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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High Anxiety (HA) group

13 participants of both genders, 19-42 years old, with no history of psychiatric disorders and scores above 41 in STAI-Trait

No interventions assigned to this group

Low Anxiety (LA) group

11 participants of both genders, 19-42 years old, with no history of psychiatric disorders and scores below 41 in STAI-Trait

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged 18 to 45 years
* Volunteers with no psychiatric history and diagnosis of vocal problem
* Have a minimum of the average school

Exclusion Criteria

* Chronic smokers
* Subjects with paralysis or neurological diseases
* Compromised upper airway at the time of the experiment
* User stimulants, psychotropic drugs, herbal medicines, tranquilizers, antidepressants
* Have drunk coffee or alcohol on the day of the experiment
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Associação Fundo de Incentivo a Psicofarmacologia

UNKNOWN

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal da Paraiba

Principal Investigators

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Anna Almeida, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal da Paraíba

Locations

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José Roberto Leite

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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142932/2006-0

Identifier Type: OTHER

Identifier Source: secondary_id

CEP/UNIFESP 0707/05

Identifier Type: -

Identifier Source: org_study_id

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