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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

Primary Purpose

Syncope

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Mauricio Ibrahim Scanavacca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syncope focused on measuring Psychotherapy, Syncope, Quality of life, Psychoanalytic psychosomatics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Psychotherapy

No psychotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Quality of life analysis performed by the Short Form 36 Instrument
Data collected at first visit
Quality of life analysis performed by the Short Form 36 Instrument
Data collected at first visit, 6 and 12 months (global assessment and by specific domains).
Quality of life analysis performed by the Short Form 36 Instrument
Data collected at 12 months (global assessment and by specific domains).

Secondary Outcome Measures

Demographic data
Gender, age, date of birth, race, monthly income and education level.
Number of comorbidities
Especially use of alcohol, drugs and smoking
Use of concomitant medication
Prescription medication that the participant uses.

Full Information

First Posted
January 21, 2020
Last Updated
January 30, 2020
Sponsor
Mauricio Ibrahim Scanavacca
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1. Study Identification

Unique Protocol Identification Number
NCT04252729
Brief Title
Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Official Title
Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
August 3, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mauricio Ibrahim Scanavacca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
Keywords
Psychotherapy, Syncope, Quality of life, Psychoanalytic psychosomatics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
Psychotherapy sessions based on the theoretical line of Psychoanalytic Psychosomatics for 1 year, every 10 days.
Arm Title
No psychotherapy
Arm Type
No Intervention
Arm Description
Follow-up according to institutional routine, without psychotherapy sessions.
Intervention Type
Procedure
Intervention Name(s)
Psychotherapy
Intervention Description
Psychotherapy sessions based on Psychoanalytic Psychosomatics
Primary Outcome Measure Information:
Title
Quality of life analysis performed by the Short Form 36 Instrument
Description
Data collected at first visit
Time Frame
1 week
Title
Quality of life analysis performed by the Short Form 36 Instrument
Description
Data collected at first visit, 6 and 12 months (global assessment and by specific domains).
Time Frame
6 months
Title
Quality of life analysis performed by the Short Form 36 Instrument
Description
Data collected at 12 months (global assessment and by specific domains).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Demographic data
Description
Gender, age, date of birth, race, monthly income and education level.
Time Frame
12 months
Title
Number of comorbidities
Description
Especially use of alcohol, drugs and smoking
Time Frame
12 months
Title
Use of concomitant medication
Description
Prescription medication that the participant uses.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35388029
Citation
de Barros E Silva RLA, Volich RM, de Barros E Silva PGM, da Costa Darrieux FC, Scanavacca MI, Hachul DT. Effect of psychotherapy on recurrence of events and quality of life in patients with vasovagal syncope. Sci Rep. 2022 Apr 6;12(1):5745. doi: 10.1038/s41598-022-09513-1.
Results Reference
derived

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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

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