Clinical Trials Logo

Clinical Trial Summary

The primary purpose of this study is to characterize cardiovascular autonomic function to emotional stimuli (blood-injection-injury phobia [needle phobia]) during an orthostatic (upright) challenge in individuals with and without known needle phobia. It is well established that emotional stress can produce hypotensive (low blood pressure) reactions. Interestingly, these hypotensive reactions to venipuncture (even with minimal blood drawn), insulin injections, finger sticks for blood sugar monitoring, dental care, and vaccinations can affect up to a quarter of adults and appear to be uniquely associated with blood-injection-injury phobia rather than other phobias. These hypotensive reactions can ultimately lead to a vasovagal syncope (fainting) response, and lead to increased avoidance of medical and dental procedures as a result of this phobia. Ultimately, this has severe implications on public health and places additional strain on the Canadian healthcare system. Currently, there is limited understanding surrounding the initiation of this response. Additionally, a comprehensive profile of cardiovascular autonomic function during exposure to provoking stimuli during orthostatic stress has not been captured in the literature. We will test individuals with and without blood-injection-injury phobia using our standard approach while exposing them to emotional stimuli.


Clinical Trial Description

The purpose of this study is to characterize cardiovascular autonomic function to emotional stimuli (blood-injection-injury phobia [needle phobia]) during an orthostatic (upright) challenge in individuals with and without known needle phobia. It is well established that emotional stress can produce hypotensive (low blood pressure) reactions. Interestingly, these hypotensive reactions to venipuncture (even with minimal blood drawn), insulin injections, finger sticks for blood sugar monitoring, dental care, and vaccinations can affect up to a quarter of adults and appear to be uniquely associated with blood-injection-injury phobia rather than other phobias. These hypotensive reactions can ultimately lead to a vasovagal syncope (fainting) response, and lead to increased avoidance of medical and dental procedures as a result of this phobia. Ultimately, this has severe implications on public health and places additional strain on the Canadian healthcare system. Currently, there is limited understanding surrounding the initiation of this response. Additionally, a comprehensive profile of cardiovascular autonomic function during exposure to provoking stimuli during orthostatic stress has not been captured in the literature. We will test individuals with and without blood-injection-injury phobia using our standard approach while exposing them to emotional stimuli. Volunteers (n=20) will be asked to undergo a "tilt test" to assess cardiovascular reflex control and orthostatic tolerance (measured as time to presyncope, or near fainting, in minutes). We and others have previously shown this technique to be reproducible, reliable, and to have high sensitivity and specificity for differentiating persons with differing orthostatic tolerance, or for examining the effects of interventions aimed at improving orthostatic tolerance. Volunteers will undergo the test on two separate days. On one test day (the order of which will be randomized) the volunteer will be shown a series of photos and videos during the upright tilt portion of the test. One day the series of content will consist of blood-injection-injury phobia content and the other day will have neutral content. Cardiovascular measures will be monitored through the test. The study will be conducted in a randomised fashion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06336031
Study type Interventional
Source Simon Fraser University
Contact Victoria E Claydon, PhD
Phone 7787828513
Email victoria_claydon@sfu.ca
Status Recruiting
Phase N/A
Start date March 30, 2024
Completion date February 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05555771 - Paediatric Syncope in the Emergency Department N/A
Completed NCT06038708 - Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
Recruiting NCT03159156 - Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation N/A
Not yet recruiting NCT05572034 - Cardiac Autonomic Denervation for Cardio-inhibitory Syncope N/A
Completed NCT05729724 - Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)
Recruiting NCT04595942 - Midodrine and Fludrocortisone for Vasovagal Syncope Phase 3
Completed NCT03903744 - Cardioneuroablation for Reflex Syncope N/A
Completed NCT05782647 - Wearable Monitor in Patients With Syncope N/A
Completed NCT00465439 - Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal N/A
Active, not recruiting NCT01621464 - Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study) Phase 4
Recruiting NCT06458140 - Cardioneuroablation and Ventricular Proarrhythmia N/A
Recruiting NCT06440291 - Cardioneuroablation for Reflex Syncope and Exercise Capacity N/A
Completed NCT01617616 - Tilt Table With Suspected Postural Orthostatic Tachycardia Syndrome (POTS) Subjects N/A
Recruiting NCT05086679 - Compression Stockings for Treating Vasovagal Syncope Trial N/A
Completed NCT04772755 - Presyncope (Syncope) Prevention Study N/A
Completed NCT03533829 - Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study N/A
Completed NCT05782699 - Detecting Syncope by an Integrated Multisensor Patch-type Recorder N/A
Completed NCT01695525 - Influence of Yoga in Patients With Neurocardiogenic Syncope Phase 0
Completed NCT00475462 - The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents N/A
Completed NCT04972123 - The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope Phase 2