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

Primary Purpose

Syncope, Vasovagal

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Applied Tension
Respiration Control
Applied Tension/Respiration Control
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Syncope, Vasovagal

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteer blood donors.

Exclusion Criteria:

-

Sites / Locations

  • McGill UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Blood Donation As Usual

Applied Tension

Respiration Control

Applied Tension/Respiration Control

Arm Description

Volunteer blood donors complete assessment materials, including assessment of respiratory activity, but otherwise undergo the typical blood donation procedure.

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.

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.

Participants are asked to practice both Applied Tension and Respiration Control before and while giving blood.

Outcomes

Primary Outcome Measures

Change in End Tidal CO2
assessed by ambulatory monitor (capnometer)
Change in Respiration Rate
assessed by ambulatory monitor (capnometer)
Blood Donation Reactions Inventory
questionnaire assessing presyncopal vasovagal symptoms
Research Assistant Observations
participant anxiety, fainting, whether or not treatment for a vasovagal response required, etc., noted by a research assistant

Secondary Outcome Measures

Change in Spielberger State Anxiety Scale Score
self-report questionnaire
Medical Fears Survey
self-report questionnaire
Change in Systolic Blood Pressure
in mmHg
Change in Diastolic Blood Pressure
in mmHg
Change in Heart Rate
in bpm
Blood Donor Return
number of times the donor returns to give blood again in a one-year time frame as reported by Hema-Quebec

Full Information

First Posted
May 15, 2017
Last Updated
May 17, 2017
Sponsor
McGill University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03159156
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2015 (Actual)
Primary Completion Date
May 31, 2018 (Anticipated)
Study Completion Date
May 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGill University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Allocation
Randomized
Enrollment
408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Donation As Usual
Arm Type
No Intervention
Arm Description
Volunteer blood donors complete assessment materials, including assessment of respiratory activity, but otherwise undergo the typical blood donation procedure.
Arm Title
Applied Tension
Arm Type
Experimental
Arm Description
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.
Arm Title
Respiration Control
Arm Type
Experimental
Arm Description
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.
Arm Title
Applied Tension/Respiration Control
Arm Type
Experimental
Arm Description
Participants are asked to practice both Applied Tension and Respiration Control before and while giving blood.
Intervention Type
Behavioral
Intervention Name(s)
Applied Tension
Intervention Description
Described above.
Intervention Type
Behavioral
Intervention Name(s)
Respiration Control
Intervention Description
Described above.
Intervention Type
Behavioral
Intervention Name(s)
Applied Tension/Respiration Control
Intervention Description
Described above.
Primary Outcome Measure Information:
Title
Change in End Tidal CO2
Description
assessed by ambulatory monitor (capnometer)
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)
Title
Change in Respiration Rate
Description
assessed by ambulatory monitor (capnometer)
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)
Title
Blood Donation Reactions Inventory
Description
questionnaire assessing presyncopal vasovagal symptoms
Time Frame
completed in the recovery area, approximately 15 minutes after blood donation
Title
Research Assistant Observations
Description
participant anxiety, fainting, whether or not treatment for a vasovagal response required, etc., noted by a research assistant
Time Frame
during blood donation
Secondary Outcome Measure Information:
Title
Change in Spielberger State Anxiety Scale Score
Description
self-report questionnaire
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
Title
Medical Fears Survey
Description
self-report questionnaire
Time Frame
completed in the recovery area, approximately 15 minutes after blood donation
Title
Change in Systolic Blood Pressure
Description
in mmHg
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
Title
Change in Diastolic Blood Pressure
Description
in mmHg
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
Title
Change in Heart Rate
Description
in bpm
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
Title
Blood Donor Return
Description
number of times the donor returns to give blood again in a one-year time frame as reported by Hema-Quebec
Time Frame
one year after participating in the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteer blood donors. Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blaine Ditto, PhD
Phone
514-398-6097
Email
blaine.ditto@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blaine Ditto, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A1B1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blaine Ditto, PhD
Phone
514-398-6097
Email
blaine.ditto@mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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