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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-27

Study Completion Date

2018-08-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Syncope

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psychotherapy

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

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type PROCEDURE

Psychotherapy sessions based on Psychoanalytic Psychosomatics

No psychotherapy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychotherapy

Psychotherapy sessions based on Psychoanalytic Psychosomatics

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No