An interventional study of blood-injection-injury (BII) phobia stimuli and neutral stimuli in Syncope, Vasovagal and Blood, Injection, Injury Type Phobia, sponsored by Simon Fraser University. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Simon Fraser University · Not applicable, Interventional, and Other
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.
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.
88 studies on the registry are indexed under Syncope, Vasovagal; 28 are open to participants now.
This study's planned enrollment of 20 is below the median of 59 across 58 interventional studies indexed under Syncope, Vasovagal.
Browse Syncope, Vasovagal studies →Simon Fraser University is the lead sponsor of 29 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Participants will undergo this test on two separate days. On each day, participants will be asked to watch a series of videos and images. For this arm of the study, participants will view the BII phobia-related stimuli.
Other: blood-injection-injury (BII) phobia stimuli
Participants will undergo this test on two separate days. On each day, participants will be asked to watch a series of videos and images. For this arm of the study, participants will view the neutral stimuli.
Other: neutral stimuli
498 seconds of BII phobia-related images and videos will begin two-minutes prior to head-up tilt test, while in supine.
498 seconds of neutral images and videos will begin two-minutes prior to head-up tilt test, while in supine.
Orthostatic Tolerance
Time (in minutes) to reach presyncope
Time frame: 0-50 minutes
Plan to share: No — Data will be presented in aggregate form and no identifiers will be included.
Started Mar 2024 (actual). Primary completion is estimated for Dec 2026, 33 months after the start.
Of 29 interventional studies with no phase under Syncope, Vasovagal, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15. This study's planned 33 months is below that.
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