None listed
Conditions
Brief summary
Introduction: Pain is an adverse effect associated with vaccination. Ice may be used to reduce pain. This prospective randomised controlled trial aims to investigate the effect of applying an ice pack prior to immunisation on the outcome of pain in medical students receiving their flu vaccines. Methods and analysis: This double-blinded, multicentre, prospective randomised controlled trial is designed to investigate impact of ice packs in reducing injection-related pain in medical students receiving influenza vaccines. The study will include 90 patients who receive influenza vaccines. An ice pack (0°C) will be applied to the site of injection for 30 seconds in participants randomised to the intervention group (n = 45). A placebo cold pack (10°C) will be applied to those in the control group (n = 45) for the same duration immediately prior to vaccination. A standardised vaccination protocol will be used across both study arms. The primary objective is to test the hypothesis that applying an ice pack will significantly reduce pain in comparison to a cold pack. Secondary objectives aim to assess any potential adverse reactions. The study commenced in January 2019 and is due for completion by December 2020. The main analysis of data will follow the intention to treat principle. The measurement of pain, the primary dependent variable, in each of the two groups will be compared using an independent t-test or a Mann-Whitney U test. Multivariable logistic regression analysis will be used if necessary.
Interventions
This double-blinded, multicentre, prospective randomised controlled trial is designed to investigate impact of ice packs in reducing injection-related pain in medical students receiving influenza vaccines at JCU health in Townsville and Mackay City Medical. The study will include 90 patients who receive influenza vaccines. An ice pack (0 degrees C) will be applied to the site of injection for 30 seconds in participants randomised to the intervention group (n = 45) immediately prior to vaccinatio
This double-blinded, multicentre, prospective randomised controlled trial is designed to investigate impact of ice packs in reducing injection-related pain in medical students receiving influenza vaccines at JCU health in Townsville and Mackay City Medical. The study will include 90 patients who receive influenza vaccines. An ice pack (0 degrees C) will be applied to the site of injection for 30 seconds in participants randomised to the intervention group (n = 45) immediately prior to vaccination. General practitioners at participating practices will be responsible for administering vaccines and ice packs/ cold-packs. Members of the research team will be present during vaccination clinics to monitor adherence to the intervention.
Sponsors
James Cook University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- All patients over the age of 18 undergoing flu vaccination at participating vaccination clinics during the study period who: o Have the capacity to give informed consent and; o Are able to return for assessment of the vaccination reaction - Patients who do not have a history of reaction to ice
Exclusion criteria
· Allergy to ice (cold anaphylaxis) · History of serious immunisation reactions · Allergy to flu vaccination
Outcome results
None listed