To Look or Not to Look at the Needle During Vaccination

Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02937428
• Other study ID #: 33392
• Status: Recruiting
• Phase: Phase 3
• First received: October 13, 2016
• Last updated: October 23, 2016
• Start date: October 2016
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: University of Toronto
• Contact: Anna Taddio, PhD
• Phone: 416-978-8822
• Email: anna.taddio[@]utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vaccination

Intervention

Behavioral:
• Look away from the needle
Participant looks away from the needle during vaccination
• Look at the needle
Participant looks at the needle during vaccination

Locations

Country	Name	City	State
Canada	Anna Taddio	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	self-reported pain assessed after vaccination using a numerical rating scale (0-10)	immediately after vaccination (<5 minutes)	No
Primary	Fear	self-reported fear assessed after vaccination using a numerical rating scale (0-10)	immediately after vaccination (<5 minutes)	No
Secondary	Recruitment rate	percentage of people eligible that participate	before vaccination (1 day to 4 weeks)	No
Secondary	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)	No
Secondary	Duration of appointment	Amount of time taken for appointment as per clock	immediately after vaccination	No
Secondary	Attrition of participants	number of participants that are lost/drop-out of study	immediately after vaccination	No
Secondary	Preferences of participants	participant preferences about interventions according to questionnaire	immediately after vaccination (<5 minutes)	No
Secondary	Fidelity of intervention	Compliance with instruction to look at the needle or look away, according to checklist	During vaccination	No