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

Anxiety Clinical Trial

Official title:

Psychophysiological and Vocal Affections in Subjects Submitted to a Public Speaking Mock Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157273
• Other study ID #: CEP/UNIFESP 0707/05
• Secondary ID: 142932/2006-0
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: July 6, 2010
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: July 2010
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anxiety
• Communication

Locations

Country	Name	City	State
Brazil	José Roberto Leite	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Associação Fundo de Incentivo a Psicofarmacologia, Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil,