Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Study Details
Study Description
Brief Summary
Recurrent vasovagal syncope although presenting a benign prognosis in terms of survival, is associated with significant impairment of quality of life. The impaired emotional status is also related to the recurrence of the events, closing a negative cycle for the evolution of the disease. This study aims to evaluate the effect of psychotherapy on the quality of life and in the number of syncope and pre-syncope events during one year of follow-up of patients with recurrent vasovagal syncope.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Psychotherapy Psychotherapy sessions based on the theoretical line of Psychoanalytic Psychosomatics for 1 year, every 10 days. |
Procedure: Psychotherapy
Psychotherapy sessions based on Psychoanalytic Psychosomatics
|
No Intervention: No psychotherapy Follow-up according to institutional routine, without psychotherapy sessions. |
Outcome Measures
Primary Outcome Measures
- Quality of life analysis performed by the Short Form 36 Instrument [1 week]
Data collected at first visit
- Quality of life analysis performed by the Short Form 36 Instrument [6 months]
Data collected at first visit, 6 and 12 months (global assessment and by specific domains).
- Quality of life analysis performed by the Short Form 36 Instrument [12 months]
Data collected at 12 months (global assessment and by specific domains).
Secondary Outcome Measures
- Demographic data [12 months]
Gender, age, date of birth, race, monthly income and education level.
- Number of comorbidities [12 months]
Especially use of alcohol, drugs and smoking
- Use of concomitant medication [12 months]
Prescription medication that the participant uses.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months)
-
Signed Free and Informed Consent Form
Exclusion Criteria:
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Severe comorbidity with life expectancy <1 year
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Age <18 years
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Current psychotherapeutic follow-up
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Cardiac or neurological syncope
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Pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Sao Paulo | SP | Brazil | 05403010 |
Sponsors and Collaborators
- Mauricio Ibrahim Scanavacca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4383/16/049