To Look or Not to Look at the Needle During Vaccination

Study Overview
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Brief Summary
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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
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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.

Official Title
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To Look or Not to Look? Pilot Study of the Effectiveness of a Simple Psychological Intervention in Reducing Vaccination Pain and Fear in Adult

Conditions
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Vaccination

Intervention / Treatment
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* Behavioral: Look away from the needle
* Behavioral: Look at the needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Look away and prefer to look<br>Participant who is self-identified as preferring to look at the needle is randomized to look away from the needle during vaccination | Behavioral: Look away from the needle<br>* Participant looks away from the needle during vaccination<br>|
| Active Comparator: Look at needle and prefer to look<br>Participant who is self-identified as preferring to look at the needle is randomized to look at the needle during vaccination | Behavioral: Look at the needle<br>* Participant looks at the needle during vaccination<br>|
| Experimental: Look away and prefer to look away<br>Participant who is self-identified as preferring to look away from the needle is randomized to look away from the needle during vaccination | Behavioral: Look away from the needle<br>* Participant looks away from the needle during vaccination<br>|
| Active Comparator: Look at needle and prefer to look away<br>Participant who is self-identified as preferring to look away from the needle is randomized to look at the needle during vaccination | Behavioral: Look at the needle<br>* Participant looks at the needle during vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | self-reported pain assessed after vaccination using a numerical rating scale (0-10) | immediately after vaccination (<5 minutes) | 
| Fear | self-reported fear assessed after vaccination using a numerical rating scale (0-10) | immediately after vaccination (<5 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | percentage of people eligible that participate | before vaccination (1 day to 4 weeks) | 
| Feasibility of recruitment of subjects in the 2 study strata (i.e., preference to look or not look) | percentage of individuals that prefer to look or not look at baseline | immediately before vaccination (<5 minutes) | 
| Duration of appointment | Amount of time taken for appointment as per clock | immediately after vaccination | 
| Attrition of participants | number of participants that are lost/drop-out of study | immediately after vaccination | 
| Preferences of participants | participant preferences about interventions according to questionnaire | immediately after vaccination (<5 minutes) | 
| Fidelity of intervention | Compliance with instruction to look at the needle or look away, according to checklist | During vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccination, pain, fear, psychological intervention