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

Syncope, Vasovagal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03159156
• Other study ID #: MOP-133459
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2017
• Last updated: May 17, 2017
• Start date: September 15, 2015
• Est. completion date: May 31, 2018

Study information

• Verified date: May 2017
• Source: McGill University
• Contact: Blaine Ditto, PhD
• Phone: 514-398-6097
• Email: blaine.ditto[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Healthy volunteer blood donors.

Exclusion Criteria:

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

Behavioral:
• Applied Tension
Described above.
• Respiration Control
Described above.
• Applied Tension/Respiration Control
Described above.

Locations

Country	Name	City	State
Canada	McGill University	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in End Tidal CO2	assessed by ambulatory monitor (capnometer)	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)
Primary	Change in Respiration Rate	assessed by ambulatory monitor (capnometer)	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)
Primary	Blood Donation Reactions Inventory	questionnaire assessing presyncopal vasovagal symptoms	completed in the recovery area, approximately 15 minutes after blood donation
Primary	Research Assistant Observations	participant anxiety, fainting, whether or not treatment for a vasovagal response required, etc., noted by a research assistant	during blood donation
Secondary	Change in Spielberger State Anxiety Scale Score	self-report questionnaire	completed just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in anxiety
Secondary	Medical Fears Survey	self-report questionnaire	completed in the recovery area, approximately 15 minutes after blood donation
Secondary	Change in Systolic Blood Pressure	in mmHg	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
Secondary	Change in Diastolic Blood Pressure	in mmHg	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
Secondary	Change in Heart Rate	in bpm	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
Secondary	Blood Donor Return	number of times the donor returns to give blood again in a one-year time frame as reported by Hema-Quebec	one year after participating in the study