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

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ClinicalTrials.gov Identifier: NCT01157273
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 7, 2010
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Associação Fundo de Incentivo a Psicofarmacologia
Information provided by:
Federal University of São Paulo

Brief 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.

Condition or disease
Anxiety Communication

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Psychophysiological and Vocal Affections in Subjects Submitted to a Public Speaking Mock Test
Study Start Date : February 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Group/Cohort
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
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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Thirty individuals participated in the study, being 18 (60.0%) female and 12 (40.0%) male. They were between 19 and 42 years old and their schooling ranged from fundamental school (primary and middle school) to post-graduation.

All the volunteers were in good health, had no history of psychiatric problems or alcohol and/or drug abuse, and did not report any vocal problems. Subjects excluded from the sample were chronic smokers; had paralysis or neurological diseases; had problems in the upper airways or allergic rhinitis at the moment of the experiment; used stimulant, psychotropic, anxiolytic, phytotherapic or antidepressant substances, and those who had ingested alcohol or coffee on the day of the experiment.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157273


Locations
Brazil
José Roberto Leite
São Paulo, Brazil, 04024-002
Sponsors and Collaborators
Federal University of São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Associação Fundo de Incentivo a Psicofarmacologia
Investigators
Principal Investigator: Anna Almeida, PhD Universidade Federal da Paraíba

Responsible Party: Anna Alice Figueiredo de Almeida, Universidade Federal da Paraiba
ClinicalTrials.gov Identifier: NCT01157273     History of Changes
Other Study ID Numbers: CEP/UNIFESP 0707/05
142932/2006-0 ( Other Identifier: CNPq )
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Federal University of São Paulo:
Behavior
Anxiety
Communication
Voice