Impact of Blood Phobia on Fainting Susceptibility

NCT ID: NCT06336031

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-30
• Study Completion Date: 2026-12-31

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 (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.

Conditions

Syncope, Vasovagal; Blood, Injection, Injury Type Phobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Image and video data set shown with BII 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 BII phobia-related stimuli.

Group Type: EXPERIMENTAL

blood-injection-injury (BII) phobia stimuli

Intervention Type: 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 neutral 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.

Group Type: PLACEBO_COMPARATOR

neutral stimuli

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

neutral stimuli

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Simon Fraser University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Victoria Claydon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria E Claydon, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Biomedical Physiology and Kinesiology

Locations

Simon Fraser University

Burnaby, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Victoria E Claydon, PhD

Role: CONTACT

victoria_claydon@sfu.ca

7787828513

Vera E Lucci, PhD

Role: CONTACT

vlucci@sfu.ca

7787828560

Facility Contacts

Vera E Lucci, PhD

Role: primary

vlucci@sfu.ca

7787828560

References

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Reference Type: BACKGROUND

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Other Identifiers

30002163

Identifier Type: -

Identifier Source: org_study_id