Clinical trial NCT03159156: Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation
Official title: Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Syncope, Vasovagal
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-05-18
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer blood donors.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in End Tidal CO2
timeFrame: 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)
measure: Change in Respiration Rate
timeFrame: 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)
measure: Blood Donation Reactions Inventory
timeFrame: completed in the recovery area, approximately 15 minutes after blood donation
measure: Research Assistant Observations
timeFrame: during blood donation
Secondary outcomes:
measure: Change in Spielberger State Anxiety Scale Score
timeFrame: completed just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in anxiety
measure: Medical Fears Survey
timeFrame: completed in the recovery area, approximately 15 minutes after blood donation
measure: Change in Systolic Blood Pressure
timeFrame: 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
measure: Change in Diastolic Blood Pressure
timeFrame: 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
measure: Change in Heart Rate
timeFrame: 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
measure: Blood Donor Return
timeFrame: one year after participating in the study
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Professor
name: Blaine Ditto, PhD
role: PRINCIPAL_INVESTIGATOR
References: