MedPath

To Look or Not to Look at the Needle During Vaccination

Phase 3
Conditions
Vaccination
Interventions
Behavioral: Look at the needle
Behavioral: Look away from the needle
Registration Number
NCT02937428
Lead Sponsor
University of Toronto
Brief Summary

It is common for people to advise individuals undergoing vaccination to look away from the needle to make them hurt less and be less scary. However, this advice is not backed up by research evidence. the purpose of this study is to learn about how looking away vs. looking at the needle during vaccination makes people feel. People will be randomized to 1 of 2 groups: look at the needle, look away. Then they will undergo vaccination and report on pain and fear experienced.

Detailed Description

It is common for people to advise individuals undergoing vaccination to look away from the needle to make them hurt less and be less scary. However, this advice is not backed up by experimental research evidence. It is possible that looking away acts as a distraction and takes attention away from the needle, thus reducing pain. However, it is also possible that looking at the needle is better because it prevents people's imaginations from making them think it is worse than it actually is. To our knowledge, this is the first first randomized study to examine the effect of looking away vs. looking at the needle on pain and fear experienced during vaccinations. Adult university students undergoing routine flu vaccination will be included.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
160
Inclusion Criteria
  • undergraduate and graduate students at the University of Toronto's Leslie Dan Faculty of Pharmacy undergoing flu vaccination
Exclusion Criteria
  • less than 18 years of age or prior participation in the trial

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Look at needle and prefer to lookLook at the needleParticipant who is self-identified as preferring to look at the needle is randomized to look at the needle during vaccination
Look away and prefer to look awayLook away from the needleParticipant who is self-identified as preferring to look away from the needle is randomized to look away from the needle during vaccination
Look away and prefer to lookLook away from the needleParticipant who is self-identified as preferring to look at the needle is randomized to look away from the needle during vaccination
Look at needle and prefer to look awayLook at the needleParticipant who is self-identified as preferring to look away from the needle is randomized to look at the needle during vaccination
Primary Outcome Measures
NameTimeMethod
Painimmediately after vaccination (<5 minutes)

self-reported pain assessed after vaccination using a numerical rating scale (0-10)

Fearimmediately after vaccination (<5 minutes)

self-reported fear assessed after vaccination using a numerical rating scale (0-10)

Secondary Outcome Measures
NameTimeMethod
Preferences of participantsimmediately after vaccination (<5 minutes)

participant preferences about interventions according to questionnaire

Recruitment ratebefore vaccination (1 day to 4 weeks)

percentage of people eligible that participate

Attrition of participantsimmediately after vaccination

number of participants that are lost/drop-out of study

Feasibility of recruitment of subjects in the 2 study strata (i.e., preference to look or not look)immediately before vaccination (<5 minutes)

percentage of individuals that prefer to look or not look at baseline

Duration of appointmentimmediately after vaccination

Amount of time taken for appointment as per clock

Fidelity of interventionDuring vaccination

Compliance with instruction to look at the needle or look away, according to checklist

Trial Locations

Locations (1)

Anna Taddio

🇨🇦

Toronto, Ontario, Canada

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