Preventing Negative Reactions in First Time Blood Donors to Encourage Subsequent Blood Donations
Primary Purpose
Syncope, Vasovagal
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pre-Donation Water Consumption
Muscle Tensing Exercise During Donation
Muscle Tensing Exercise Prior to Donation
Sponsored by
About this trial
This is an interventional prevention trial for Syncope, Vasovagal focused on measuring Blood Donation, Syncope, Vasovagal Reactions
Eligibility Criteria
Inclusion Criteria: Must meet American Red Cross donor eligibility requirements Exclusion Criteria: No more than two prior blood donations
Sites / Locations
- Ohio University
- American Red Cross Blood Services - Central Ohio Region
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
No Intervention
Arm Label
1
2
3
4
Arm Description
Pre-donation water and muscle tension during donation
Pre-donation water
Pre-donation muscle tension
Standard donation
Outcomes
Primary Outcome Measures
Participant ratings of negative (vasovagal) reactions
Phlebotomist ratings of donor reactions
Number of repeat donations
Secondary Outcome Measures
Subjective ratings of muscle soreness and fatigue
Negative (vasovagal) reactions
Full Information
NCT ID
NCT00302900
First Posted
March 14, 2006
Last Updated
October 4, 2016
Sponsor
Ohio University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00302900
Brief Title
Preventing Negative Reactions in First Time Blood Donors to Encourage Subsequent Blood Donations
Official Title
Preventing Adverse Reactions in Novice Blood Donors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal
Keywords
Blood Donation, Syncope, Vasovagal Reactions
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
441 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pre-donation water and muscle tension during donation
Arm Title
2
Arm Type
Experimental
Arm Description
Pre-donation water
Arm Title
3
Arm Type
Sham Comparator
Arm Description
Pre-donation muscle tension
Arm Title
4
Arm Type
No Intervention
Arm Description
Standard donation
Intervention Type
Behavioral
Intervention Name(s)
Pre-Donation Water Consumption
Intervention Description
Consumption of 500 ml of bottled water 30 minutes prior to donating
Intervention Type
Behavioral
Intervention Name(s)
Muscle Tensing Exercise During Donation
Intervention Description
Alternating leg lifts at 10-second intervals during donation
Intervention Type
Behavioral
Intervention Name(s)
Muscle Tensing Exercise Prior to Donation
Intervention Description
Alternating leg lifts at 10-second intervals prior to insertion of the donation needle
Primary Outcome Measure Information:
Title
Participant ratings of negative (vasovagal) reactions
Time Frame
Measured within 30 minutes of donating
Title
Phlebotomist ratings of donor reactions
Time Frame
Measured immediately following donation
Title
Number of repeat donations
Time Frame
Measured 2 years post-donation
Secondary Outcome Measure Information:
Title
Subjective ratings of muscle soreness and fatigue
Time Frame
Measured 24 hours post-donation
Title
Negative (vasovagal) reactions
Time Frame
Measured 24 hours post-donation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must meet American Red Cross donor eligibility requirements
Exclusion Criteria:
No more than two prior blood donations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R. France, PhD
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
American Red Cross Blood Services - Central Ohio Region
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data is available upon request from the primary investigator.
Learn more about this trial
Preventing Negative Reactions in First Time Blood Donors to Encourage Subsequent Blood Donations
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