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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00302900
First received: March 14, 2006
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

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
Syncope, Vasovagal
Behavioral: Pre-Donation Water Consumption
Behavioral: Muscle Tensing Exercise During Donation
Behavioral: Muscle Tensing Exercise Prior to Donation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Adverse Reactions in Novice Blood Donors

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Participant ratings of negative (vasovagal) reactions [ Time Frame: Measured within 30 minutes of donating ] [ Designated as safety issue: No ]
  • Phlebotomist ratings of donor reactions [ Time Frame: Measured immediately following donation ] [ Designated as safety issue: Yes ]
  • Number of repeat donations [ Time Frame: Measured 2 years post-donation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective ratings of muscle soreness and fatigue [ Time Frame: Measured 24 hours post-donation ] [ Designated as safety issue: No ]
  • Negative (vasovagal) reactions [ Time Frame: Measured 24 hours post-donation ] [ Designated as safety issue: No ]

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
Experimental: 1
Pre-donation water and muscle tension during donation
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
Experimental: 2
Pre-donation water
Behavioral: Pre-Donation Water Consumption
Consumption of 500 ml of bottled water 30 minutes prior to donating
Sham Comparator: 3
Pre-donation muscle tension
Behavioral: Muscle Tensing Exercise Prior to Donation
Alternating leg lifts at 10-second intervals prior to insertion of the donation needle
No Intervention: 4
Standard donation

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must meet American Red Cross donor eligibility requirements

Exclusion Criteria:

  • No more than two prior blood donations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302900

Locations
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
American Red Cross Blood Services - Central Ohio Region
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Investigators
Principal Investigator: Christopher R. France, PhD Ohio University
  More Information

No publications provided

Responsible Party: Christopher France, PhD, Ohio University
ClinicalTrials.gov Identifier: NCT00302900     History of Changes
Other Study ID Numbers: 371, R01 HL077438-01A2
Study First Received: March 14, 2006
Last Updated: February 17, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Blood Donation
Syncope
Vasovagal Reactions

Additional relevant MeSH terms:
Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases

ClinicalTrials.gov processed this record on August 18, 2014