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OpenTrials
Completed

NCT Number: NCT04252729

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

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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Key information

Conditions

Syncope Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychotherapy

Procedure

Psychotherapy sessions based on Psychoanalytic Psychosomatics

Primary outcomes

  1. Quality of life analysis performed by the Short Form 36 Instrument

    Time frame: 1 week

    Data collected at first visit

  2. Quality of life analysis performed by the Short Form 36 Instrument

    Time frame: 6 months

    Data collected at first visit, 6 and 12 months (global assessment and by specific domains).

  3. 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

  1. Demographic data

    Time frame: 12 months

    Gender, age, date of birth, race, monthly income and education level.

  2. Number of comorbidities

    Time frame: 12 months

    Especially use of alcohol, drugs and smoking

  3. Use of concomitant medication

    Time frame: 12 months

    Prescription medication that the participant uses.

Sponsors and collaborators

Lead sponsor

Mauricio Ibrahim Scanavacca

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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