Blood DonorsNCT03835299
Addressing Fear and Risk of Vasovagal Reactions Among High School Donors
A study testing Fear Intervention in people with Blood Donors, run by Ohio University at 1 site in United States.
Trial summary
In this study, high school donors will be asked about their blood donation-related fears prior to their donation. Half of the donors reporting fear will be assigned to a brief coping skills intervention. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Blood Donors
- What is being tested?
- Fear Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,035 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2019to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be eligible for inclusion in this study, the individual must have presented to donate blood at a New York Blood Center high school blood drive where data is being collected and have passed the health screening process.
Who cannot join
- Less than 16 years of age; inability to read and comprehend English
Trial locations and contacts
1 site in 1 country.
About this study
In this study, high school donors will be asked about their blood donation-related fears prior to their donation. Half of the donors reporting fear will be assigned to a brief coping skills intervention.
Read the detailed description
In this study the investigators will ask high school donors about their blood donation-related fears prior to their donation. Among those who report donation fear, half will be randomly assigned to receive a brief presentation of coping strategies administered via a computer tablet. The investigators will compare reaction rates and return behavior for the donors and high school drives where the study was conducted to the reaction and retention rates from similar blood drives where no data was collected. The investigators will also examine whether asking about the specific types of fear improves the prediction of syncopal or presyncopal reactions beyond the predictive value of a single fear question. Finally, the investigators will examine whether providing coping information to help manage the fear improves syncopal reaction rates and/or donor retention rates among fearful donors.
- Conditions
- Blood Donors
- Being tested
- Fear Intervention
- Keywords
- blood donor, fear, vasovagal reaction
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear InterventionBehavioural
Coping information related to the fear that was identified by the participant will be presented via a computer tablet.
| Study group | Role | What they receive |
|---|---|---|
| Fear Control | No intervention | Participants who report blood donation-related fear who are assigned to this study arm will answer several questions then proceed through the normal blood donation process. |
| Fear Intervention | Experimental | Participants who report blood donation-related fear who are assigned to this study arm will answer several questions and view a brief presentation of coping strategies presented via a computer tablet. They will then proceed through the normal blood donation process. Receives: Behavioral: Fear Intervention |
| No Fear Control | No intervention | Participants who report no blood donation-related fear will proceed through the normal blood donation process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat Blood Donation Attempts
Donor records will be used to track subsequent donation attempts during the follow-up.
Measured: two years post-donation
Secondary outcomes (2)
Blood Donation Confidence
Confidence in ability to cope with any donation-related fear
Measured: immediately pre-donation
Vasovagal Reactions to Blood Donation
phlebotomist ratings of blood donor vasovagal reactions
Measured: immediately post-donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start15 Feb 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Blood Center
- Responsible party
- Principal investigator, Christopher R. France, Ph.D., Ohio University
- Investigators
- Christopher R France, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835299
- Sponsor's protocol ID
- NYBC 1243761
- Status last verified
- Sep 2021
- First submitted
- 7 Feb 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Fear and Risk of Vasovagal Reactions Among High School Donors
- ClinicalTrials.gov ID
- NCT03835299
- Acronym / sponsor ID
- NYBC 1243761
- Conditions
- Blood Donors
- Keywords
- blood donor, fear, vasovagal reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,035 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- New York Blood Center
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, high school donors will be asked about their blood donation-related fears prior to their donation. Half of the donors reporting fear will be assigned to a brief coping skills intervention.
Detailed description
In this study the investigators will ask high school donors about their blood donation-related fears prior to their donation. Among those who report donation fear, half will be randomly assigned to receive a brief presentation of coping strategies administered via a computer tablet. The investigators will compare reaction rates and return behavior for the donors and high school drives where the study was conducted to the reaction and retention rates from similar blood drives where no data was collected. The investigators will also examine whether asking about the specific types of fear improves the prediction of syncopal or presyncopal reactions beyond the predictive value of a single fear question. Finally, the investigators will examine whether providing coping information to help manage the fear improves syncopal reaction rates and/or donor retention rates among fearful donors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fear Control | No intervention | –Participants who report blood donation-related fear who are assigned to this study arm will answer several questions then proceed through the normal blood donation process. |
| Fear Intervention | Experimental | Behavioral: Fear InterventionParticipants who report blood donation-related fear who are assigned to this study arm will answer several questions and view a brief presentation of coping strategies presented via a computer tablet. They will then proceed through the normal blood donation process. |
| No Fear Control | No intervention | –Participants who report no blood donation-related fear will proceed through the normal blood donation process. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible for inclusion in this study, the individual must have presented to donate blood at a New York Blood Center high school blood drive where data is being collected and have passed the health screening process.
Key exclusion criteria (1 listed)
- Less than 16 years of age; inability to read and comprehend English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fear InterventionCoping information related to the fear that was identified by the participant will be presented via a computer tablet. | Behavioural | Fear Intervention |
Primary outcome
Repeat Blood Donation Attempts
Time frame: two years post-donation
Donor records will be used to track subsequent donation attempts during the follow-up.
2 secondary outcomes
Blood Donation Confidence
Time frame: immediately pre-donation
Vasovagal Reactions to Blood Donation
Time frame: immediately post-donation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R France, PhD principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fear Intervention in people with Blood Donors, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeat Blood Donation Attempts (time frame: two years post-donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.