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

October 4, 2016 updated by: Ohio University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

441

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University
      • Columbus, Ohio, United States, 43205
        • American Red Cross Blood Services - Central Ohio Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must meet American Red Cross donor eligibility requirements

Exclusion Criteria:

  • No more than two prior blood donations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant ratings of negative (vasovagal) reactions
Time Frame: Measured within 30 minutes of donating
Measured within 30 minutes of donating
Phlebotomist ratings of donor reactions
Time Frame: Measured immediately following donation
Measured immediately following donation
Number of repeat donations
Time Frame: Measured 2 years post-donation
Measured 2 years post-donation

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective ratings of muscle soreness and fatigue
Time Frame: Measured 24 hours post-donation
Measured 24 hours post-donation
Negative (vasovagal) reactions
Time Frame: Measured 24 hours post-donation
Measured 24 hours post-donation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Christopher R. France, PhD, Ohio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 14, 2006

First Submitted That Met QC Criteria

March 14, 2006

First Posted (Estimate)

March 15, 2006

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 371
  • R01HL077438 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified data is available upon request from the primary investigator.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe