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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00302900 |
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.
Condition | Intervention | Phase |
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Syncope, Vasovagal |
Behavioral: Pre-Donation Water Consumption Behavioral: Muscle Tensing Exercise During Donation Behavioral: Muscle Tensing Exercise Prior to Donation |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Preventing Adverse Reactions in Novice Blood Donors |
Estimated Enrollment: | 400 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pre-donation water and muscle tension during donation
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Behavioral: Pre-Donation Water Consumption
Consumption of 500 ml of bottled water 30 minutes prior to donating
Behavioral: Muscle Tensing Exercise During Donation
Alternating leg lifts at 10-second intervals during donation
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2: Experimental
Pre-donation water
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Behavioral: Pre-Donation Water Consumption
Consumption of 500 ml of bottled water 30 minutes prior to donating
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3: Sham Comparator
Pre-donation muscle tension
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Behavioral: Muscle Tensing Exercise Prior to Donation
Alternating leg lifts at 10-second intervals prior to insertion of the donation needle
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4: No Intervention
Standard donation
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Ohio University | |
Athens, Ohio, United States, 45701 | |
American Red Cross Blood Services - Central Ohio Region | |
Columbus, Ohio, United States, 43205 |
Principal Investigator: | Christopher R. France, PhD | Ohio University |
Responsible Party: | Ohio University ( Christopher France, PhD ) |
Study ID Numbers: | 371, R01 HL077438-01A2 |
Study First Received: | March 14, 2006 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00302900 History of Changes |
Health Authority: | United States: Federal Government |
Blood Donation Syncope Vasovagal Reactions |
Signs and Symptoms Unconsciousness Consciousness Disorders Neurologic Manifestations |
Neurobehavioral Manifestations Syncope Syncope, Vasovagal |
Signs and Symptoms Unconsciousness Nervous System Diseases Consciousness Disorders |
Neurologic Manifestations Neurobehavioral Manifestations Syncope Syncope, Vasovagal |