Impact of Blood Phobia on Fainting Susceptibility

NCT06336031 | Recruiting

• 1 other identifier: 30002163
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope, Vasovagal; Blood, Injection, Injury Type Phobia

Keywords

tilt table

Outcome Measures

Primary Outcomes (1)

• Orthostatic Tolerance

  Time (in minutes) to reach presyncope

  0-50 minutes

Study Arms (2)

Image and video data set shown with BII stimuli.

EXPERIMENTAL

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

Image and video data set shown with neutral stimuli.

PLACEBO COMPARATOR

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

Interventions

blood-injection-injury (BII) phobia stimuli OTHER

498 seconds of BII phobia-related images and videos will begin two-minutes prior to head-up tilt test, while in supine.

Image and video data set shown with BII stimuli.

neutral stimuli OTHER

498 seconds of neutral images and videos will begin two-minutes prior to head-up tilt test, while in supine.

Image and video data set shown with neutral stimuli.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male and female
• to 50 years old
• those without a suspected BII fear and those with a suspected fear
• english speaking

You may not qualify if:

• diagnosis of any cardiovacular or neurological disorder
• menopausal
• taking medication for a cardiovascular condition
• if they are pregnant

Sponsors & Collaborators

• Simon Fraser University: lead

Study Sites (1)

Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

RECRUITING

Related Publications (13)

• 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.

  PMID: 28780134 BACKGROUND

• 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.

  PMID: 17335637 BACKGROUND

• 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.

  PMID: 22670781 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10823336 BACKGROUND

• 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.

  PMID: 11198483 BACKGROUND

• 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.

  PMID: 14981050 BACKGROUND

• 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.

  PMID: 14564654 BACKGROUND

• 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.

  PMID: 8054836 BACKGROUND

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

  PMID: 11571497 BACKGROUND

• 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.

  PMID: 12357276 BACKGROUND

• 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.

  PMID: 16321141 BACKGROUND

• 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.

  PMID: 12451007 BACKGROUND

MeSH Terms

Conditions

Syncope, Vasovagal

Interventions

Calcium Channels, R-Type

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium Channels, N-Type; Calcium Channels; Ion Channels; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Glycoproteins; Membrane Proteins

Study Officials

• Victoria E Claydon, PhD

  Professor, Biomedical Physiology and Kinesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria E Claydon, PhD

CONTACT

7787828513; victoria_claydon@sfu.ca

Vera E Lucci, PhD

CONTACT

7787828560; vlucci@sfu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 28, 2024
• Study Start: March 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)