Impact of Blood Phobia on Fainting Susceptibility

April 15, 2024 updated by: Dr. Victoria Claydon, Simon Fraser University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Vera E Lucci, PhD
  • Phone Number: 7787828560
  • Email: vlucci@sfu.ca

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5A 1S6
        • Recruiting
        • Simon Fraser University
        • Principal Investigator:
          • Victoria E Claydon, PhD
        • Contact:
          • Vera E Lucci, PhD
          • Phone Number: 7787828560
          • Email: vlucci@sfu.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
Other: neutral stimuli
498 seconds of neutral images and videos will begin two-minutes prior to head-up tilt test, while in supine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthostatic Tolerance
Time Frame: 0-50 minutes
Time (in minutes) to reach presyncope
0-50 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simon Fraser University

Investigators

  • Principal Investigator: Victoria E Claydon, PhD, Professor, Biomedical Physiology and Kinesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30002163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be presented in aggregate form and no identifiers will be included.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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