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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preventing Adverse Reactions in Novice Blood Donors

Conditions
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Syncope, Vasovagal

Intervention / Treatment
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* Behavioral: Pre-Donation Water Consumption
* Behavioral: Muscle Tensing Exercise During Donation
* Behavioral: Muscle Tensing Exercise Prior to Donation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must meet American Red Cross donor eligibility requirements Exclusion Criteria: No more than two prior blood donations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Donation, Syncope, Vasovagal Reactions