Syncope, VasovagalNCT03159156
Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation
A study testing Applied Tension in people with Syncope, Vasovagal, run by McGill University at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- Applied Tension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2015to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer blood donors.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal, Quebec, H3A1B1
Blaine Ditto, PhD, 514-398-6097, blaine.ditto@mcgill.ca
About this study
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.
Read the detailed description
See above.
- Conditions
- Syncope, Vasovagal
- Being tested
- Applied Tension, Respiration Control, Applied Tension/Respiration Control
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied TensionBehavioural
Described above.
Respiration ControlBehavioural
Described above.
Applied Tension/Respiration ControlBehavioural
Described above.
| Study group | Role | What they receive |
|---|---|---|
| Blood Donation As Usual | No intervention | Volunteer blood donors complete assessment materials, including assessment of respiratory activity, but otherwise undergo the typical blood donation procedure. |
| Applied Tension | Experimental | 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. Receives: Behavioral: Applied Tension |
| Respiration Control | Experimental | 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. Receives: Behavioral: Respiration Control |
| Applied Tension/Respiration Control | Experimental | Participants are asked to practice both Applied Tension and Respiration Control before and while giving blood. Receives: Behavioral: Applied Tension/Respiration Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in End Tidal CO2
assessed by ambulatory monitor (capnometer)
Measured: 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)
Change in Respiration Rate
assessed by ambulatory monitor (capnometer)
Measured: 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)
Blood Donation Reactions Inventory
questionnaire assessing presyncopal vasovagal symptoms
Measured: completed in the recovery area, approximately 15 minutes after blood donation
Research Assistant Observations
participant anxiety, fainting, whether or not treatment for a vasovagal response required, etc., noted by a research assistant
Measured: during blood donation
Secondary outcomes (6)
Change in Spielberger State Anxiety Scale Score
self-report questionnaire
Measured: completed just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in anxiety
Medical Fears Survey
self-report questionnaire
Measured: completed in the recovery area, approximately 15 minutes after blood donation
Change in Systolic Blood Pressure
in mmHg
Measured: 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 Diastolic Blood Pressure
in mmHg
Measured: 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
in bpm
Measured: 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
Blood Donor Return
number of times the donor returns to give blood again in a one-year time frame as reported by Hema-Quebec
Measured: one year after participating in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start15 Sep 2015
- Primary completion31 May 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Blaine Ditto, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159156
- Sponsor's protocol ID
- MOP-133459
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation
- ClinicalTrials.gov ID
- NCT03159156
- Acronym / sponsor ID
- MOP-133459
- Conditions
- Syncope, Vasovagal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blood Donation As Usual | No intervention | –Volunteer blood donors complete assessment materials, including assessment of respiratory activity, but otherwise undergo the typical blood donation procedure. |
| Applied Tension | Experimental | Behavioral: Applied TensionParticipants 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. |
| Respiration Control | Experimental | Behavioral: Respiration ControlParticipants 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. |
| Applied Tension/Respiration Control | Experimental | Behavioral: Applied Tension/Respiration ControlParticipants are asked to practice both Applied Tension and Respiration Control before and while giving blood. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteer blood donors.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applied TensionDescribed above. | Behavioural | Applied Tension |
| Respiration ControlDescribed above. | Behavioural | Respiration Control |
| Applied Tension/Respiration ControlDescribed above. | Behavioural | Applied Tension/Respiration Control |
Primary outcome
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)
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)
Blood Donation Reactions Inventory
Time frame: completed in the recovery area, approximately 15 minutes after blood donation
questionnaire assessing presyncopal vasovagal symptoms
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
6 secondary outcomes
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
Medical Fears Survey
Time frame: completed in the recovery area, approximately 15 minutes after blood donation
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
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
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
Blood Donor Return
Time frame: one year after participating in the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Syncope, Vasovagal
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
Recruiting
Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial
Colorectal Neoplasia, Screening Colonoscopy
Active, not recruitingObservational study
A Warning Red Flag Classification System to Predict Risk of Vasovagal Event During Office Hysteroscopy
Vasovagal Syncope (VVS), Presyncope
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blaine Ditto, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied Tension in people with Syncope, Vasovagal, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blaine Ditto, PhD (514-398-6097, blaine.ditto@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.