Recruiting

Observational Study

Sponsor:

Simon Fraser University

Code:

NCT06336031

Conditions

Syncope, Vasovagal

Blood, Injection, Injury Type Phobia

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

blood-injection-injury (BII) phobia stimuli

neutral stimuli

Study Details

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

Study ID

NCT06336031

Start date

Mar 30, 2024

Status verified date

May, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

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.

neutral stimuli

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

Primary outcome measure

  • Orthostatic Tolerance [ Time Frame: 0-50 minutes ]

Central Contacts and Locations

Central contacts

Victoria E Claydon, PhD

7787828513victoria_claydon@sfu.ca

Vera E Lucci, PhD

7787828560vlucci@sfu.ca

Locations

Simon Fraser University

Recruiting

Burnaby, British Columbia, Canada, V5A 1S6

Contacts

Vera E Lucci, PhD

7787828560vlucci@sfu.ca

Principal Investigator:

Victoria E Claydon, PhD

More Information

Sponsor

Simon Fraser University

Last update posted

May 15, 2025

Last verified

May, 2025

Keywords

  • tilt table

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Simon Fraser University on 2025-05-15.