Clinical trial NCT02937428: To Look or Not to Look at the Needle During Vaccination
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vaccination
Keywords: vaccination
pain
fear
psychological intervention
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: immediately after vaccination (<5 minutes)
measure: Fear
timeFrame: immediately after vaccination (<5 minutes)
Secondary outcomes:
measure: Recruitment rate
timeFrame: before vaccination (1 day to 4 weeks)
measure: Feasibility of recruitment of subjects in the 2 study strata (i.e., preference to look or not look)
timeFrame: immediately before vaccination (<5 minutes)
measure: Duration of appointment
timeFrame: immediately after vaccination
measure: Attrition of participants
timeFrame: immediately after vaccination
measure: Preferences of participants
timeFrame: immediately after vaccination (<5 minutes)
measure: Fidelity of intervention
timeFrame: During vaccination
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Anna Taddio
state: Ontario
Study officials:
References:
citation: 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.