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To Look or Not to Look at the Needle During Vaccination

NCT ID: NCT02937428

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-03-31

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.

Conditions

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Vaccination

Keywords

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vaccination pain fear psychological intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Look away from the needle

Intervention Type BEHAVIORAL

Participant looks away from the needle during vaccination

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

Group Type ACTIVE_COMPARATOR

Look at the needle

Intervention Type BEHAVIORAL

Participant looks at the needle during vaccination

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

Group Type EXPERIMENTAL

Look away from the needle

Intervention Type BEHAVIORAL

Participant looks away from the needle during vaccination

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

Group Type ACTIVE_COMPARATOR

Look at the needle

Intervention Type BEHAVIORAL

Participant looks at the needle during vaccination

Interventions

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Look away from the needle

Participant looks away from the needle during vaccination

Intervention Type BEHAVIORAL

Look at the needle

Participant looks at the needle during vaccination

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Anna Taddio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anna Taddio

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anna Taddio, PhD

Role: CONTACT

Phone: 416-978-8822

Email: [email protected]

Facility Contacts

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Anna Taddio, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35005359 (View on PubMed)

Other Identifiers

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33392

Identifier Type: -

Identifier Source: org_study_id