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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252729
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Syncope Procedure: Psychotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : August 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Experimental: Psychotherapy
Psychotherapy sessions based on the theoretical line of Psychoanalytic Psychosomatics for 1 year, every 10 days.
Procedure: Psychotherapy
Psychotherapy sessions based on Psychoanalytic Psychosomatics

No Intervention: No psychotherapy
Follow-up according to institutional routine, without psychotherapy sessions.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252729


Locations
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Brazil
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, SP, Brazil, 05403010
Sponsors and Collaborators
Mauricio Ibrahim Scanavacca
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Responsible Party: Mauricio Ibrahim Scanavacca, Arrhythmia Clinical Unit Director, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04252729    
Other Study ID Numbers: 4383/16/049
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital:
Psychotherapy
Syncope
Quality of life
Psychoanalytic psychosomatics
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Recurrence
Disease Attributes
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases