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

• Sponsor: Mauricio Ibrahim Scanavacca (Other)
• Overall Status: Completed
• CT.gov ID: NCT04252729
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Syncope	Procedure: Psychotherapy	N/A

Study Design

• Study Type: Interventional
• 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: Jul 27, 2017
• Actual Primary Completion Date: Aug 3, 2018
• Actual Study Completion Date: Aug 23, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

   Data collected at first visit

2. Quality of life analysis performed by the Short Form 36 Instrument [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 [12 months]

   Data collected at 12 months (global assessment and by specific domains).

Secondary Outcome Measures

1. Demographic data [12 months]

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

2. Number of comorbidities [12 months]

   Especially use of alcohol, drugs and smoking

3. Use of concomitant medication [12 months]

   Prescription medication that the participant uses.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Feb 5, 2020
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mauricio Ibrahim Scanavacca, Arrhythmia Clinical Unit Director, University of Sao Paulo General Hospital: Psychotherapy; Syncope; Quality of life; Psychoanalytic psychosomatics
• Additional relevant MeSH terms: Syncope; Syncope, Vasovagal; Recurrence

Study Results

No Results Posted as of Feb 5, 2020