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

Mauricio Ibrahim Scanavacca

Status: Completed

Conditions: Syncope

Treatments: Procedure: Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04252729

4383/16/049

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Psychotherapy

Experimental group

Description:

Psychotherapy sessions based on the theoretical line of Psychoanalytic Psychosomatics for 1 year, every 10 days.

Treatment:

Procedure: Psychotherapy

No psychotherapy

No Intervention group

Description:

Follow-up according to institutional routine, without psychotherapy sessions.