Syncope, VasovagalPhase 2NCT00302900
Preventing Negative Reactions in First Time Blood Donors to Encourage Subsequent Blood Donations
A Phase 2 study testing Pre-Donation Water Consumption, Muscle Tensing Exercise During Donation and Muscle Tensing Exercise Prior to Donation in people with Syncope, Vasovagal, run by Ohio University at 2 sites in United States.
Trial summary
Many individuals experience negative reactions when donating blood, including dizziness, lightheadedness, or fainting. Such reactions may discourage them from donating again. This study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing exercise during donation to reduce negative… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- Pre-Donation Water Consumption, Muscle Tensing Exercise During Donation and Muscle Tensing Exercise Prior to Donation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 441 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Mar 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must meet American Red Cross donor eligibility requirements
Who cannot join
- No more than two prior blood donations
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio University
Athens, Ohio, 45701
American Red Cross Blood Services - Central Ohio Region
Columbus, Ohio, 43205
About this study
Official title: Preventing Adverse Reactions in Novice Blood Donors
Many individuals experience negative reactions when donating blood, including dizziness, lightheadedness, or fainting. Such reactions may discourage them from donating again. This study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing exercise during donation to reduce negative reactions among new blood donors. This study will also evaluate whether reducing negative reactions increases the likelihood of donors returning to give blood in the future.
Read the detailed description
Severe and potentially dangerous shortages in the blood supply are increasingly common in the United States. As the population ages and as more stringent donor eligibility restrictions are enforced, blood shortages are expected to worsen. One way to meet the increasing demand for blood is to recruit new blood donors. Ideally, these individuals would become lifelong donors, and contribute up to six times per year and up to hundreds of units of blood within a lifetime. Unfortunately, less than half of all new donors provide a second donation. Many individuals who donate blood experience dizziness, weakness, lightheadedness, or in severe cases, fainting. As a result of these negative reactions, many individuals never donate blood again. Preventing these reactions may be an effective way to encourage subsequent blood donations. The purpose of this study is to evaluate the effectiveness of consuming water prior to donation and performing a muscle tensing exercise during donation as ways to reduce negative reactions in new blood donors. The study's long-term goal is to provide blood collection agencies with simple and inexpensive strategies to prevent negative reactions and enhance donor retention.
This study will enroll American Red Cross blood donors who have donated blood no more than twice previously. Participants will be randomly assigned to one of the following four groups: 1) pre-donation water consumption and muscle tensing exercise during donation; 2) pre-donation water consumption; 3) pre-donation muscle tensing exercise; or 4) no treatment. Participant reactions will be assessed at the time of donation by self-report and phlebotomist ratings, as well as by self-report 24 hours following the donation. Participants' subsequent donation history will be tracked for two years by reviewing the American Red Cross national donor database.
- Conditions
- Syncope, Vasovagal
- Being tested
- Pre-Donation Water Consumption, Muscle Tensing Exercise During Donation, Muscle Tensing Exercise Prior to Donation
- Keywords
- Blood Donation, Syncope, Vasovagal Reactions
- Medical subject headings
- Syncope, Vasovagal, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Donation Water ConsumptionBehavioural
Consumption of 500 ml of bottled water 30 minutes prior to donating
Muscle Tensing Exercise During DonationBehavioural
Alternating leg lifts at 10-second intervals during donation
Muscle Tensing Exercise Prior to DonationBehavioural
Alternating leg lifts at 10-second intervals prior to insertion of the donation needle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pre-donation water and muscle tension during donation Receives: Behavioral: Pre-Donation Water Consumption; Behavioral: Muscle Tensing Exercise During Donation |
| 2 | Experimental | Pre-donation water Receives: Behavioral: Pre-Donation Water Consumption |
| 3 | Sham comparator | Pre-donation muscle tension Receives: Behavioral: Muscle Tensing Exercise Prior to Donation |
| 4 | No intervention | Standard donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant ratings of negative (vasovagal) reactions
Measured: Measured within 30 minutes of donating
Phlebotomist ratings of donor reactions
Measured: Measured immediately following donation
Number of repeat donations
Measured: Measured 2 years post-donation
Secondary outcomes (2)
Subjective ratings of muscle soreness and fatigue
Measured: Measured 24 hours post-donation
Negative (vasovagal) reactions
Measured: Measured 24 hours post-donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2010
- Study completionMar 2010
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christopher R. France, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302900
- Sponsor's protocol ID
- 371
- Other IDs
- R01HL077438
- Status last verified
- Feb 2009
- First submitted
- 14 Mar 2006
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Deidentified data is available upon request from the primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Adverse Reactions in Novice Blood Donors
- ClinicalTrials.gov ID
- NCT00302900
- Acronym / sponsor ID
- 371
- Conditions
- Syncope, Vasovagal
- Keywords
- Blood Donation, Syncope, Vasovagal Reactions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Mar 2006 (estimated)
- 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.
Many individuals experience negative reactions when donating blood, including dizziness, lightheadedness, or fainting. Such reactions may discourage them from donating again. This study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing exercise during donation to reduce negative reactions among new blood donors. This study will also evaluate whether reducing negative reactions increases the likelihood of donors returning to give blood in the future.
Detailed description
Severe and potentially dangerous shortages in the blood supply are increasingly common in the United States. As the population ages and as more stringent donor eligibility restrictions are enforced, blood shortages are expected to worsen. One way to meet the increasing demand for blood is to recruit new blood donors. Ideally, these individuals would become lifelong donors, and contribute up to six times per year and up to hundreds of units of blood within a lifetime. Unfortunately, less than half of all new donors provide a second donation. Many individuals who donate blood experience dizziness, weakness, lightheadedness, or in severe cases, fainting. As a result of these negative reactions, many individuals never donate blood again. Preventing these reactions may be an effective way to encourage subsequent blood donations. The purpose of this study is to evaluate the effectiveness of consuming water prior to donation and performing a muscle tensing exercise during donation as ways to reduce negative reactions in new blood donors. The study's long-term goal is to provide blood collection agencies with simple and inexpensive strategies to prevent negative reactions and enhance donor retention.
This study will enroll American Red Cross blood donors who have donated blood no more than twice previously. Participants will be randomly assigned to one of the following four groups: 1) pre-donation water consumption and muscle tensing exercise during donation; 2) pre-donation water consumption; 3) pre-donation muscle tensing exercise; or 4) no treatment. Participant reactions will be assessed at the time of donation by self-report and phlebotomist ratings, as well as by self-report 24 hours following the donation. Participants' subsequent donation history will be tracked for two years by reviewing the American Red Cross national donor database.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Pre-Donation Water Consumption, Behavioral: Muscle Tensing Exercise During DonationPre-donation water and muscle tension during donation |
| 2 | Experimental | Behavioral: Pre-Donation Water ConsumptionPre-donation water |
| 3 | Sham comparator | Behavioral: Muscle Tensing Exercise Prior to DonationPre-donation muscle tension |
| 4 | No intervention | –Standard donation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must meet American Red Cross donor eligibility requirements
Key exclusion criteria (1 listed)
- No more than two prior blood donations
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 |
|---|---|---|
| Pre-Donation Water ConsumptionConsumption of 500 ml of bottled water 30 minutes prior to donating | Behavioural | 1, 2 |
| Muscle Tensing Exercise During DonationAlternating leg lifts at 10-second intervals during donation | Behavioural | 1 |
| Muscle Tensing Exercise Prior to DonationAlternating leg lifts at 10-second intervals prior to insertion of the donation needle | Behavioural | 3 |
Primary outcome
Participant ratings of negative (vasovagal) reactions
Time frame: Measured within 30 minutes of donating
Phlebotomist ratings of donor reactions
Time frame: Measured immediately following donation
Number of repeat donations
Time frame: Measured 2 years post-donation
2 secondary outcomes
Subjective ratings of muscle soreness and fatigue
Time frame: Measured 24 hours post-donation
Negative (vasovagal) reactions
Time frame: Measured 24 hours post-donation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Individual participant dataSharing planned: Yes. Deidentified data is available upon request from the primary investigator.
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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.
Christopher R. France, PhD principal investigator
Ohio University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pre-Donation Water Consumption, Muscle Tensing Exercise During Donation and Muscle Tensing Exercise Prior to Donation in people with Syncope, Vasovagal, run by Ohio University at 2 sites in United States.
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: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant ratings of negative (vasovagal) reactions (time frame: Measured within 30 minutes of donating). The study lists 3 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 6 Oct 2016.