Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study

Syncope Clinical Trial

Official title:

Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252729
• Other study ID #: 4383/16/049
• Status: Completed
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: August 23, 2018

Study information

• Verified date: January 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 23, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Syncope
• Syncope, Vasovagal

Intervention

Procedure:
• Psychotherapy
Psychotherapy sessions based on Psychoanalytic Psychosomatics

Locations

Country	Name	City	State
Brazil	Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Mauricio Ibrahim Scanavacca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life analysis performed by the Short Form 36 Instrument	Data collected at first visit	1 week
Primary	Quality of life analysis performed by the Short Form 36 Instrument	Data collected at first visit, 6 and 12 months (global assessment and by specific domains).	6 months
Primary	Quality of life analysis performed by the Short Form 36 Instrument	Data collected at 12 months (global assessment and by specific domains).	12 months
Secondary	Demographic data	Gender, age, date of birth, race, monthly income and education level.	12 months
Secondary	Number of comorbidities	Especially use of alcohol, drugs and smoking	12 months
Secondary	Use of concomitant medication	Prescription medication that the participant uses.	12 months