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Preventing Negative Reactions in First Time Blood Donors to Encourage Subsequent Blood Donations

Preventing Adverse Reactions in Novice Blood Donors

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00302900
Enrollment
441
Registered
2006-03-15
Start date
2006-01-31
Completion date
2010-03-31
Last updated
2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope, Vasovagal

Keywords

Blood Donation, Syncope, Vasovagal Reactions

Brief 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 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.

Interventions

BEHAVIORALPre-Donation Water Consumption

Consumption of 500 ml of bottled water 30 minutes prior to donating

BEHAVIORALMuscle Tensing Exercise During Donation

Alternating leg lifts at 10-second intervals during donation

BEHAVIORALMuscle Tensing Exercise Prior to Donation

Alternating leg lifts at 10-second intervals prior to insertion of the donation needle

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Ohio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Must meet American Red Cross donor eligibility requirements

Exclusion criteria

* No more than two prior blood donations

Design outcomes

Primary

MeasureTime frame
Participant ratings of negative (vasovagal) reactionsMeasured within 30 minutes of donating
Phlebotomist ratings of donor reactionsMeasured immediately following donation
Number of repeat donationsMeasured 2 years post-donation

Secondary

MeasureTime frame
Subjective ratings of muscle soreness and fatigueMeasured 24 hours post-donation
Negative (vasovagal) reactionsMeasured 24 hours post-donation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026