Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Quality of life analysis performed by the Short Form 36 Instrument
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Severe comorbidity with life expectancy <1 year
- •Age <18 years
- •Current psychotherapeutic follow-up
- •Cardiac or neurological syncope
- •Pregnancy
Outcomes
Primary Outcomes
Quality of life analysis performed by the Short Form 36 Instrument
Time Frame: 12 months
Data collected at 12 months (global assessment and by specific domains).
Secondary Outcomes
- Number of comorbidities(12 months)
- Use of concomitant medication(12 months)
- Demographic data(12 months)
Investigators
Mauricio Ibrahim Scanavacca
Arrhythmia Clinical Unit Director
University of Sao Paulo General Hospital