SyncopeNCT04252729
Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
A study testing Psychotherapy in people with Syncope, run by Mauricio Ibrahim Scanavacca at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Psychotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Jul 2017to 23 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months)
- Signed Free and Informed Consent Form
Who cannot join
- Severe comorbidity with life expectancy <1 year
- Age <18 years
- Current psychotherapeutic follow-up
- Cardiac or neurological syncope
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403010
About this 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.
- Conditions
- Syncope
- Being tested
- Psychotherapy
- Keywords
- Psychotherapy, Syncope, Quality of life, Psychoanalytic psychosomatics
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyProcedure or surgery
Psychotherapy sessions based on Psychoanalytic Psychosomatics
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Psychotherapy sessions based on the theoretical line of Psychoanalytic Psychosomatics for 1 year, every 10 days. Receives: Procedure: Psychotherapy |
| No psychotherapy | No intervention | Follow-up according to institutional routine, without psychotherapy sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life analysis performed by the Short Form 36 Instrument
Data collected at first visit
Measured: 1 week
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).
Measured: 6 months
Quality of life analysis performed by the Short Form 36 Instrument
Data collected at 12 months (global assessment and by specific domains).
Measured: 12 months
Secondary outcomes (3)
Demographic data
Gender, age, date of birth, race, monthly income and education level.
Measured: 12 months
Number of comorbidities
Especially use of alcohol, drugs and smoking
Measured: 12 months
Use of concomitant medication
Prescription medication that the participant uses.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start27 Jul 2017
- Primary completion3 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mauricio Ibrahim Scanavacca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252729
- Sponsor's protocol ID
- 4383/16/049
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35388029
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04252729
- Acronym / sponsor ID
- 4383/16/049
- Conditions
- Syncope
- Keywords
- Psychotherapy, Syncope, Quality of life, Psychoanalytic psychosomatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mauricio Ibrahim ScanavaccaUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Procedure: PsychotherapyPsychotherapy sessions based on the theoretical line of Psychoanalytic Psychosomatics for 1 year, every 10 days. |
| No psychotherapy | No intervention | –Follow-up according to institutional routine, without psychotherapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months)
- Signed Free and Informed Consent Form
Key exclusion criteria (5 listed)
- Severe comorbidity with life expectancy <1 year
- Age <18 years
- Current psychotherapeutic follow-up
- Cardiac or neurological syncope
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyPsychotherapy sessions based on Psychoanalytic Psychosomatics | Procedure or surgery | Psychotherapy |
Primary outcome
Quality of life analysis performed by the Short Form 36 Instrument
Time frame: 1 week
Data collected at first visit
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).
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).
3 secondary outcomes
Demographic data
Time frame: 12 months
Number of comorbidities
Time frame: 12 months
Use of concomitant medication
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 35388029de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Syncope, run by Mauricio Ibrahim Scanavacca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life analysis performed by the Short Form 36 Instrument (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.