AnxietyNCT01157273
Evaluation of Physiological and Vocal Parameters in Volunteers of Both Genders Submitted to an Anxiogenic Task
An observational study of Anxiety and Communication, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Communication
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Aged 18 to 45 years
- Volunteers with no psychiatric history and diagnosis of vocal problem
- Have a minimum of the average school
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychophysiological and Vocal Affections in Subjects Submitted to a Public Speaking Mock Test
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.
- Conditions
- Anxiety, Communication
- Keywords
- Behavior, Anxiety, Communication, Voice
- Medical subject headings
- Anxiety Disorders, Communication, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startFeb 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Associação Fundo de Incentivo a Psicofarmacologia
- Investigators
- Anna Almeida, PhD, Principal investigator, Universidade Federal da Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157273
- Sponsor's protocol ID
- CEP/UNIFESP 0707/05
- Other IDs
- 142932/2006-0
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological and Vocal Affections in Subjects Submitted to a Public Speaking Mock Test
- ClinicalTrials.gov ID
- NCT01157273
- Acronym / sponsor ID
- CEP/UNIFESP 0707/05
- Conditions
- Anxiety, Communication
- Keywords
- Behavior, Anxiety, Communication, Voice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Associação Fundo de Incentivo a Psicofarmacologia
- Study start
- Feb 2009
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Aged 18 to 45 years
- Volunteers with no psychiatric history and diagnosis of vocal problem
- Have a minimum of the average school
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Almeida, PhD principal investigator
Universidade Federal da Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Communication, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.