Counterpressure Maneuvers for Vasovagal Syncope

BC Children's Hospital, Vancouver, Canada
Vasovagal Syncope+2 More ConditionsCounterpressure Maneuvers - Behavioral
Eligibility
6 - 18
All Sexes
What conditions do you have?
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Study Summary

This trial will assess whether counterpressure maneuvers (CPM) can prevent syncope in children. In stage I, participants will fill out a survey about their syncopal episode and any prodromal symptoms. In stage II, some participants will be trained in CPM and all will be followed for one year. Surveys and medical records will be used to assess syncopal and presyncopal recurrence and changes in medical diagnosis.

Eligible Conditions
  • Fainting
  • Vasovagal Syncope
  • Postural Orthostatic Tachycardia Syndrome (POTS)
  • Orthostatic Intolerance

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: One year

One year
Documentation of typical prodromal symptoms
Exercise-related syncope in pediatric patients
Number of patients with exercise-related syncope
Number of patients with syncope secondary to other causes
Syncope
Syncope
One year, reported in monthly surveys.
Syncope
Syncope

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Counterpressure Maneuvers
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Counterpressure Maneuvers · No Placebo Group · N/A

Counterpressure Maneuvers
Behavioral
Experimental Group · 1 Intervention: Counterpressure Maneuvers · Intervention Types: Behavioral
Usual Care
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

University of British ColumbiaOTHER
1,353 Previous Clinical Trials
1,564,459 Total Patients Enrolled
Dr. Victoria ClaydonLead Sponsor
Simon Fraser UniversityOTHER
50 Previous Clinical Trials
8,902 Total Patients Enrolled
1 Trials studying Vasovagal Syncope
25 Patients Enrolled for Vasovagal Syncope
Provincial Health Services AuthorityOTHER
34 Previous Clinical Trials
28,954 Total Patients Enrolled
Shubhayan Sanatani, MDPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
186 Total Patients Enrolled

Eligibility Criteria

Age 6 - 18 · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Does this experiment accommodate geriatric individuals?

"This clinical trial is inviting individuals between the age of 6 and 18 to participate." - Anonymous Online Contributor

Unverified Answer

Is recruitment for this medical research still open?

"Affirmative. It is discernible from the information on clinicaltrials.gov that this medical trial, which was originally advertised on September 3rd 2022, is actively recruiting individuals to participate in it. A total of 300 participants need to be admitted across 1 healthcare centre." - Anonymous Online Contributor

Unverified Answer

What does the research team hope to accomplish through this investigation?

"This study aims to evaluate the number of patients with syncopal recurrence over a 12 month period. Secondary objectives are to define predictive factors for syncope secondary to other causes, determine diagnosis in pediatric patients who may experience exercise-related syncope, and document typical prodromal symptoms that link different types of syncope in the pediatric population after 1 year follow up." - Anonymous Online Contributor

Unverified Answer

Who has the requisite qualifications to join this medical study?

"Candidates that would like to take part in this medical trial must possess syncope, be younger than 18 years old and older than 6 years. The maximum amount of participants allowed is 300 individuals." - Anonymous Online Contributor

Unverified Answer

How many participants have been recruited for this experiment?

"Affirmative. As per the data posted on clinicaltrials.gov, this trial currently requires participants and was first listed on September 3rd 2022. The most recent changes were made November 10th 2022 and 300 people are needed from a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.