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Completed

NCT Number: NCT00302900

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ohio University, Athens, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must meet American Red Cross donor eligibility requirements

Exclusion criteria

  • No more than two prior blood donations

Treatment and study plan

Pre-Donation Water Consumption

Behavioral

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

Muscle Tensing Exercise During Donation

Behavioral

Alternating leg lifts at 10-second intervals during donation

Muscle Tensing Exercise Prior to Donation

Behavioral

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

Primary outcomes

  1. Participant ratings of negative (vasovagal) reactions

    Time frame: Measured within 30 minutes of donating

  2. Phlebotomist ratings of donor reactions

    Time frame: Measured immediately following donation

  3. Number of repeat donations

    Time frame: Measured 2 years post-donation

Secondary outcomes

  1. Subjective ratings of muscle soreness and fatigue

    Time frame: Measured 24 hours post-donation

  2. Negative (vasovagal) reactions

    Time frame: Measured 24 hours post-donation

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Preventing Adverse Reactions in Novice Blood Donors

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 15, 2006
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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