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

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Ohio University

Status and phase

Completed
Phase 2

Conditions

Syncope, Vasovagal

Treatments

Behavioral: Pre-Donation Water Consumption
Behavioral: Muscle Tensing Exercise During Donation
Behavioral: Muscle Tensing Exercise Prior to Donation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00302900
371
R01HL077438 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

441 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Must meet American Red Cross donor eligibility requirements

Exclusion criteria

  • No more than two prior blood donations

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

441 participants in 4 patient groups

1
Experimental group
Description:
Pre-donation water and muscle tension during donation
Treatment:
Behavioral: Pre-Donation Water Consumption
Behavioral: Muscle Tensing Exercise During Donation
2
Experimental group
Description:
Pre-donation water
Treatment:
Behavioral: Pre-Donation Water Consumption
3
Sham Comparator group
Description:
Pre-donation muscle tension
Treatment:
Behavioral: Muscle Tensing Exercise Prior to Donation
4
No Intervention group
Description:
Standard donation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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