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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04252729
Enrollment
10
Registered
2020-02-05
Start date
2017-07-27
Completion date
2018-08-23
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope

Keywords

Psychotherapy, Syncope, Quality of life, Psychoanalytic psychosomatics

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.

Interventions

PROCEDUREPsychotherapy

Psychotherapy sessions based on Psychoanalytic Psychosomatics

Sponsors

Mauricio Ibrahim Scanavacca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life analysis performed by the Short Form 36 Instrument1 weekData collected at first visit

Secondary

MeasureTime frameDescription
Demographic data12 monthsGender, age, date of birth, race, monthly income and education level.
Number of comorbidities12 monthsEspecially use of alcohol, drugs and smoking
Use of concomitant medication12 monthsPrescription medication that the participant uses.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026