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

NCT ID: NCT00302900

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 441 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-03-31

Brief Summary

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.

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.

Conditions

Syncope, Vasovagal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Pre-donation water and muscle tension during donation

Group Type: EXPERIMENTAL

Pre-Donation Water Consumption

Intervention Type: BEHAVIORAL

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

Muscle Tensing Exercise During Donation

Intervention Type: BEHAVIORAL

Alternating leg lifts at 10-second intervals during donation

2

Pre-donation water

Group Type: EXPERIMENTAL

Pre-Donation Water Consumption

Intervention Type: BEHAVIORAL

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

3

Pre-donation muscle tension

Group Type: SHAM_COMPARATOR

Muscle Tensing Exercise Prior to Donation

Intervention Type: BEHAVIORAL

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

4

Standard donation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre-Donation Water Consumption

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

Intervention Type: BEHAVIORAL

Muscle Tensing Exercise During Donation

Alternating leg lifts at 10-second intervals during donation

Intervention Type: BEHAVIORAL

Muscle Tensing Exercise Prior to Donation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Must meet American Red Cross donor eligibility requirements

Exclusion Criteria

• No more than two prior blood donations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Ohio University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher R. France, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio University

Locations

Ohio University

Athens, Ohio, United States

American Red Cross Blood Services - Central Ohio Region

Columbus, Ohio, United States

Countries

United States

Other Identifiers

R01HL077438

Identifier Type: NIH

Identifier Source: secondary_id

View Link

371

Identifier Type: -

Identifier Source: org_study_id