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Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03159156
Recruitment Status : Unknown
Verified May 2017 by McGill University.
Recruitment status was:  Recruiting
First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McGill University

Brief Summary:

For a number of years, researchers have examined the effects of the muscle-tensing technique, Applied Tension (AT), on blood donation-related vasovagal symptoms and donor retention. AT was developed originally to reduce symptoms and avoidance behaviour in people with strong fears of blood and needles (phobics). It was based on the idea that exercise-related increases in blood pressure might be able to counteract the effects of stimuli that lead to a decrease in delivery of blood to the brain. AT was adapted for non-phobic blood donors and significant reductions in self-reported vasovagal symptoms and the need for nurse-initiated treatment as well as increases in donor retention were observed in some groups.

That said, individual response to AT is quite variable. This is probably related to recent research indicating that exercise-related maintenance of heart rate and blood pressure plays only a minor role in reducing vasovagal symptoms. Rather, AT appears to be working at least in part by regulating breathing and reducing the possibility of hyperventilation. Pilot results suggest that a novel intervention aimed specifically at breathing may be more effective and reliable than traditional AT. To evaluate this idea, 408 blood donors at mobile clinics in colleges and universities will be assigned randomly to four conditions. In brief, 5-minute preparation sessions using a notebook computer, donors will either learn a respiration control technique to avoid hyperventilation, AT, both, or neither. As a manipulation check and also a means of examining mechanisms of the interventions, e.g., the possibility that AT may work by regulating breathing and CO2, participants will wear non-invasive portable capnometers while they are giving blood. Outcome will also be assessed by self-report of vasovagal symptoms, observational data, and number of return visits to a blood clinic in the following year verified by the provincial blood collection agency, Héma-Québec. As a secondary aim, the research will examine possible moderating effects of pre-donation anxiety and sex.

The development of simple, effective approaches to reduce vasovagal symptoms during blood donation has the potential to improve the blood donation experience and blood donor retention as well as encourage people who have never given blood to consider the procedure. It will also improve medical and dental care more generally given the use of needles in so many procedures.


Condition or disease Intervention/treatment Phase
Syncope, Vasovagal Behavioral: Applied Tension Behavioral: Respiration Control Behavioral: Applied Tension/Respiration Control Not Applicable

Detailed Description:
See above.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The primary goal is to examine the role of hyperventilation in blood donation-related vasovagal reactions and whether breathing is influenced by two treatments (alone and in combination) for reactions. The study will examine the clinical impact of these treatments but this is not the primary goal of the project.
Masking: None (Open Label)
Masking Description: Behavioral procedures that cannot be masked to participant or others.
Primary Purpose: Basic Science
Official Title: Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation
Actual Study Start Date : September 15, 2015
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
No Intervention: Blood Donation As Usual
Volunteer blood donors complete assessment materials, including assessment of respiratory activity, but otherwise undergo the typical blood donation procedure.
Experimental: Applied Tension
Participants are taught a simple muscle tensing technique with a brief video presented on a notebook computer before giving blood. They are asked to engage in repeated gentle 5-sec on, 5-sec off cycles of whole body isometric muscle tension before and while giving blood.
Behavioral: Applied Tension
Described above.

Experimental: Respiration Control
Participants are taught a simple respiration control technique with a brief video presented on a notebook computer before giving blood. They are asked to breathe in a gentle shallow but regular fashion aimed at reducing risk for hyperventilation before and while giving blood.
Behavioral: Respiration Control
Described above.

Experimental: Applied Tension/Respiration Control
Participants are asked to practice both Applied Tension and Respiration Control before and while giving blood.
Behavioral: Applied Tension/Respiration Control
Described above.




Primary Outcome Measures :
  1. Change in End Tidal CO2 [ Time Frame: change in mean value during the pre-donation waiting period (registration to going to chair, approximately 30 minutes) to the mean value in the donation chair (approximately 15 minutes) ]
    assessed by ambulatory monitor (capnometer)

  2. Change in Respiration Rate [ Time Frame: change in mean value during the pre-donation waiting period (registration to going to chair, approximately 30 minutes) to the mean value in the donation chair (approximately 15 minutes) ]
    assessed by ambulatory monitor (capnometer)

  3. Blood Donation Reactions Inventory [ Time Frame: completed in the recovery area, approximately 15 minutes after blood donation ]
    questionnaire assessing presyncopal vasovagal symptoms

  4. Research Assistant Observations [ Time Frame: during blood donation ]
    participant anxiety, fainting, whether or not treatment for a vasovagal response required, etc., noted by a research assistant


Secondary Outcome Measures :
  1. Change in Spielberger State Anxiety Scale Score [ Time Frame: completed just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in anxiety ]
    self-report questionnaire

  2. Medical Fears Survey [ Time Frame: completed in the recovery area, approximately 15 minutes after blood donation ]
    self-report questionnaire

  3. Change in Systolic Blood Pressure [ Time Frame: measured just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in blood pressure ]
    in mmHg

  4. Change in Diastolic Blood Pressure [ Time Frame: measured just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in blood pressure ]
    in mmHg

  5. Change in Heart Rate [ Time Frame: measured just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in heart rate ]
    in bpm

  6. Blood Donor Return [ Time Frame: one year after participating in the study ]
    number of times the donor returns to give blood again in a one-year time frame as reported by Hema-Quebec



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer blood donors.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159156


Contacts
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Contact: Blaine Ditto, PhD 514-398-6097 blaine.ditto@mcgill.ca

Locations
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Canada, Quebec
McGill University Recruiting
Montréal, Quebec, Canada, H3A1B1
Contact: Blaine Ditto, PhD    514-398-6097    blaine.ditto@mcgill.ca   
Sponsors and Collaborators
McGill University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Blaine Ditto, PhD Professor

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Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT03159156    
Other Study ID Numbers: MOP-133459
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases