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

This study has been completed.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Associação Fundo de Incentivo a Psicofarmacologia
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01157273
First received: July 6, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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
Anxiety
Communication

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Psychophysiological and Vocal Affections in Subjects Submitted to a Public Speaking Mock Test

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Enrollment: 24
Study Start Date: February 2009
Study Completion Date: July 2009
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: Brazil: National Health Surveillance Agency

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014