Clinical trial NCT00302900: Preventing Negative Reactions in First Time Blood Donors to Encourage Subsequent Blood Donations
Official title: Preventing Adverse Reactions in Novice Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Syncope, Vasovagal
Keywords: Blood Donation
Syncope
Vasovagal Reactions
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-03-15
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Must meet American Red Cross donor eligibility requirements

Exclusion Criteria:

* No more than two prior blood donations

Primary outcomes:
measure: Participant ratings of negative (vasovagal) reactions
timeFrame: Measured within 30 minutes of donating
measure: Phlebotomist ratings of donor reactions
timeFrame: Measured immediately following donation
measure: Number of repeat donations
timeFrame: Measured 2 years post-donation
Secondary outcomes:
measure: Subjective ratings of muscle soreness and fatigue
timeFrame: Measured 24 hours post-donation
measure: Negative (vasovagal) reactions
timeFrame: Measured 24 hours post-donation
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
city: Columbus
country: United States
facility: American Red Cross Blood Services - Central Ohio Region
state: Ohio
Study officials:
affiliation: Ohio University
name: Christopher R. France, PhD
role: PRINCIPAL_INVESTIGATOR
References: