Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336031
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-15
Brief Title:
Impact of Blood Phobia on Fainting Susceptibility
Sponsor:
Simon Fraser University
Organization:
Simon Fraser University
Study Overview
Official Title:
Impact of Blood Phobia on Fainting Susceptibility
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 n20 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
Volunteers n20 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None