Impact of Blood Phobia on Fainting Susceptibility

Syncope, Vasovagal Clinical Trial

Official title:

Impact of Blood Phobia on Fainting Susceptibility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336031
• Other study ID #: 30002163
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Simon Fraser University
• Contact: Victoria E Claydon, PhD
• Phone: 7787828513
• Email: victoria_claydon[@]sfu.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• male and female

• 18 to 50 years old

• those without a suspected BII fear and those with a suspected fear

• english speaking

Exclusion Criteria:

• diagnosis of any cardiovacular or neurological disorder

• menopausal

• taking medication for a cardiovascular condition

• if they are pregnant

Related Conditions & MeSH terms

• Blood, Injection, Injury Type Phobia
• Phobic Disorders
• Syncope
• Syncope, Vasovagal

Intervention

Other:
• blood-injection-injury (BII) phobia stimuli
498 seconds of BII phobia-related images and videos will begin two-minutes prior to head-up tilt test, while in supine.
• neutral stimuli
498 seconds of neutral images and videos will begin two-minutes prior to head-up tilt test, while in supine.

Locations

Country	Name	City	State
Canada	Simon Fraser University	Burnaby	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Simon Fraser University

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Brown CM, Hainsworth R. Forearm vascular responses during orthostatic stress in control subjects and patients with posturally related syncope. Clin Auton Res. 2000 Apr;10(2):57-61. doi: 10.1007/BF02279892. — View Citation

Bush VE, Wight VL, Brown CM, Hainsworth R. Vascular responses to orthostatic stress in patients with postural tachycardia syndrome (POTS), in patients with low orthostatic tolerance, and in asymptomatic controls. Clin Auton Res. 2000 Oct;10(5):279-84. doi: 10.1007/BF02281110. — View Citation

Claydon VE, Hainsworth R. Cerebral autoregulation during orthostatic stress in healthy controls and in patients with posturally related syncope. Clin Auton Res. 2003 Oct;13(5):321-9. doi: 10.1007/s10286-003-0120-8. — View Citation

Claydon VE, Hainsworth R. Salt supplementation improves orthostatic cerebral and peripheral vascular control in patients with syncope. Hypertension. 2004 Apr;43(4):809-13. doi: 10.1161/01.HYP.0000122269.05049.e7. Epub 2004 Feb 23. — View Citation

Claydon VE, Schroeder C, Norcliffe LJ, Jordan J, Hainsworth R. Water drinking improves orthostatic tolerance in patients with posturally related syncope. Clin Sci (Lond). 2006 Mar;110(3):343-52. doi: 10.1042/CS20050279. — View Citation

Cooper VL, Hainsworth R. Carotid baroreceptor reflexes in humans during orthostatic stress. Exp Physiol. 2001 Sep;86(5):677-81. doi: 10.1113/eph8602213. — View Citation

Cooper VL, Hainsworth R. Effects of dietary salt on orthostatic tolerance, blood pressure and baroreceptor sensitivity in patients with syncope. Clin Auton Res. 2002 Aug;12(4):236-41. doi: 10.1007/s10286-002-0018-x. — View Citation

el-Bedawi KM, Hainsworth R. Combined head-up tilt and lower body suction: a test of orthostatic tolerance. Clin Auton Res. 1994 Apr;4(1-2):41-7. doi: 10.1007/BF01828837. — View Citation

France CR, France JL, Himawan LK, Stephens KY, Frame-Brown TA, Venable GA, Menitove JE. How afraid are you of having blood drawn from your arm? A simple fear question predicts vasovagal reactions without causing them among high school donors. Transfusion. 2013 Feb;53(2):315-21. doi: 10.1111/j.1537-2995.2012.03726.x. Epub 2012 Jun 7. — View Citation

Schroeder C, Bush VE, Norcliffe LJ, Luft FC, Tank J, Jordan J, Hainsworth R. Water drinking acutely improves orthostatic tolerance in healthy subjects. Circulation. 2002 Nov 26;106(22):2806-11. doi: 10.1161/01.cir.0000038921.64575.d0. — View Citation

Stinson FS, Dawson DA, Patricia Chou S, Smith S, Goldstein RB, June Ruan W, Grant BF. The epidemiology of DSM-IV specific phobia in the USA: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Psychol Med. 2007 Jul;37(7):1047-59. doi: 10.1017/S0033291707000086. Epub 2007 Mar 5. — View Citation

Trost Z, Jones A, Guck A, Vervoort T, Kowalsky JM, France CR. Initial validation of a virtual blood draw exposure paradigm for fear of blood and needles. J Anxiety Disord. 2017 Oct;51:65-71. doi: 10.1016/j.janxdis.2017.03.002. Epub 2017 Mar 16. — View Citation

Y. M. A. Al Shamma, R. Hainsworth, in Cardiogenic Reflexes. (Eds: R. Hainsworth, P.N. McWilliam, D.S.A.. Mary), OUP, Oxford, 1987, p. 431_ _-432.

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orthostatic Tolerance	Time (in minutes) to reach presyncope	0-50 minutes