To Look or Not to Look at the Needle During Vaccination

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

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.

Study Overview

• Status: Unknown
• Conditions: Vaccination
• Intervention / Treatment: Behavioral: Look away from the needle; Behavioral: Look at the needle

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 3M2
      • Recruiting
      • Anna Taddio
      • Principal Investigator: Pamela Simmons, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Look away and prefer to look; 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; Participant looks away from the needle during vaccination
Active Comparator: Look at needle and prefer to look; 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; Participant looks at the needle during vaccination
Experimental: Look away and prefer to look away; 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; Participant looks away from the needle during vaccination
Active Comparator: Look at needle and prefer to look away; 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; Participant looks at the needle during vaccination

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Toronto

Publications and helpful links

General Publications

• Mithal P, Simmons P, Cornelissen T, Wong H, Pillai Riddell R, McMurtry CM, Burry L, Stephens D, Taddio A. To look or not to look during vaccination: A pilot randomized trial. Can J Pain. 2018 Jan 5;2(1):1-8. doi: 10.1080/24740527.2017.1412254. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 23, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: pain; vaccination; fear; psychological intervention
• Other Study ID Numbers: 33392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO