- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03159156
Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Blaine Ditto, PhD
- Phone Number: 514-398-6097
- Email: blaine.ditto@mcgill.ca
Study Locations
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Quebec
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Montréal, Quebec, Canada, H3A1B1
- Recruiting
- McGill University
-
Contact:
- Blaine Ditto, PhD
- Phone Number: 514-398-6097
- Email: blaine.ditto@mcgill.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteer blood donors.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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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.
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Described above.
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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.
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Described above.
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EXPERIMENTAL: Applied Tension/Respiration Control
Participants are asked to practice both Applied Tension and Respiration Control before and while giving blood.
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Described above.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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assessed by ambulatory monitor (capnometer)
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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)
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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)
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assessed by ambulatory monitor (capnometer)
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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)
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Blood Donation Reactions Inventory
Time Frame: completed in the recovery area, approximately 15 minutes after blood donation
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questionnaire assessing presyncopal vasovagal symptoms
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completed in the recovery area, approximately 15 minutes after blood donation
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Research Assistant Observations
Time Frame: during blood donation
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participant anxiety, fainting, whether or not treatment for a vasovagal response required, etc., noted by a research assistant
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during blood donation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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self-report questionnaire
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completed just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in anxiety
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Medical Fears Survey
Time Frame: completed in the recovery area, approximately 15 minutes after blood donation
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self-report questionnaire
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completed in the recovery area, approximately 15 minutes after blood donation
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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
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in mmHg
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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
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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
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in mmHg
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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
|
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
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in bpm
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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
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Blood Donor Return
Time Frame: one year after participating in the study
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number of times the donor returns to give blood again in a one-year time frame as reported by Hema-Quebec
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one year after participating in the study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Blaine Ditto, PhD, Professor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOP-133459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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