NCT02937428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

October 13, 2016

Last Update Submit

October 23, 2016

Conditions

Vaccination

Keywords

vaccinationpainfearpsychological intervention

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Recruitment rate

    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)

    immediately before vaccination (<5 minutes)

  • Duration of appointment

    immediately after vaccination

  • Attrition of participants

    immediately after vaccination

  • Preferences of participants

    immediately after vaccination (<5 minutes)

  • +1 more secondary outcomes

Study Arms (4)

Look away and prefer to look

EXPERIMENTAL

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

Look at needle and prefer to look

ACTIVE COMPARATOR

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

Look away and prefer to look away

EXPERIMENTAL

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

Look at needle and prefer to look away

ACTIVE COMPARATOR

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

Interventions

Look away from the needleBEHAVIORAL

Participant looks away from the needle during vaccination

Look away and prefer to lookLook away and prefer to look away
Look at the needleBEHAVIORAL

Participant looks at the needle during vaccination

Look at needle and prefer to lookLook at needle and prefer to look away

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergraduate and graduate students at the University of Toronto's Leslie Dan Faculty of Pharmacy undergoing flu vaccination

You may not qualify if:

  • less than 18 years of age or prior participation in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anna Taddio

Toronto, Ontario, M5S 3M2, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35005359DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Taddio, PhD

CONTACT

416-978-8822anna.taddio@utoronto.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)