Capturing physiological responses to blood donation using a portable sensor

Not Applicable

Completed

• Conditions: Vasovagal/pre faint symptoms in voluntary whole blood and apheresis plasma donors; Signs and Symptoms

• Registration Number: ISRCTN17105027
• Lead Sponsor: Australian Red Cross Lifeblood

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-07
• Study Completion: 2022-05-16
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 522

Inclusion Criteria

1. Eligible to donate as per the Australian Red Cross Lifeblood Guidelines for the Selection of Blood Donors
2. Donating whole blood or plasma for the first time
3. Willing and able to provide informed consent
4. Has a plasma or whole blood appointment at one of the participating donor centres (appointment made as a walk-in donor or scheduled appointment)

Exclusion Criteria

1. Unwilling or unable to provide informed consent
2. Lack of understanding of the English language necessary to complete questionnaires. This study will not use translation services or interpreters
3. Contacted for a research study in the last 6 months as per Lifeblood contact policy
4. Donors with therapeutic, autologous, sample or platelet donation appointments
5. Lifeblood employees

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Self-reported vasovagal symptoms measured using the Blood Donation Reactions Inventory (BDRI) at the haemoglobin test, needle insertion, first red cell return (plasma only), saline administration (plasma only), needle removal, and post-donation<br>2. Donation fear measured using a single fear question pre- and post-donation<br>3. Venipuncture pain measured using a self-report post-donation<br>4. Donor anxiety measured using the Blood Donor Anxiety Scale post-donation<br>5. Donor satisfaction with biometric sensor device measured using a self-report post-donation

Secondary Outcome Measures

Name	Time	Method
1. Staff-recorded vasovagal reactions measured using Australian Red Cross Lifeblood standard procedures at any point at the donation centre<br>2. Donor return measured using Australian Red Cross Lifeblood records at 6-month follow-up<br>3. Time taken to return measured using the donor’s next attendance date as recorded by Australian Red Cross Lifeblood at 6-month follow up