VaccinationPhase 3NCT02937428
To Look or Not to Look at the Needle During Vaccination
A Phase 3 study testing Look away from the needle and Look at the needle in people with Vaccination, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- Look away from the needle and Look at the needle
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergraduate and graduate students at the University of Toronto's Leslie Dan Faculty of Pharmacy undergoing flu vaccination
Who cannot join
- less than 18 years of age or prior participation in the trial
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Anna Taddio
Toronto, Ontario, M5S 3M2
Anna Taddio, PhD, 416-978-8822, anna.taddio@utoronto.ca
Pamela Simmons, RN
About this study
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
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.
Read the 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.
- Conditions
- Vaccination
- Being tested
- Look away from the needle, Look at the needle
- Keywords
- vaccination, pain, fear, psychological intervention
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Look away from the needleBehavioural
Participant looks away from the needle during vaccination
Look at the needleBehavioural
Participant looks at the needle during vaccination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Look at the needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
self-reported pain assessed after vaccination using a numerical rating scale (0-10)
Measured: immediately after vaccination (<5 minutes)
Fear
self-reported fear assessed after vaccination using a numerical rating scale (0-10)
Measured: immediately after vaccination (<5 minutes)
Secondary outcomes (6)
Recruitment rate
percentage of people eligible that participate
Measured: 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
Measured: immediately before vaccination (<5 minutes)
Duration of appointment
Amount of time taken for appointment as per clock
Measured: immediately after vaccination
Attrition of participants
number of participants that are lost/drop-out of study
Measured: immediately after vaccination
Preferences of participants
participant preferences about interventions according to questionnaire
Measured: immediately after vaccination (<5 minutes)
Fidelity of intervention
Compliance with instruction to look at the needle or look away, according to checklist
Measured: During vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937428
- Sponsor's protocol ID
- 33392
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 35005359
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02937428
- Acronym / sponsor ID
- 33392
- Conditions
- Vaccination
- Keywords
- vaccination, pain, fear, psychological intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Look away and prefer to look | Experimental | Behavioral: Look away from the needleParticipant who is self-identified as preferring to look at the needle is randomized to look away from the needle during vaccination |
| Look at needle and prefer to look | Active comparator | Behavioral: Look at the needleParticipant who is self-identified as preferring to look at the needle is randomized to look at the needle during vaccination |
| Look away and prefer to look away | Experimental | Behavioral: Look away from the needleParticipant who is self-identified as preferring to look away from the needle is randomized to look away from the needle during vaccination |
| Look at needle and prefer to look away | Active comparator | Behavioral: Look at the needleParticipant who is self-identified as preferring to look away from the needle is randomized to look at the needle during vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergraduate and graduate students at the University of Toronto's Leslie Dan Faculty of Pharmacy undergoing flu vaccination
Key exclusion criteria (1 listed)
- less than 18 years of age or prior participation in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Look away from the needleParticipant looks away from the needle during vaccination | Behavioural | Look away and prefer to look, Look away and prefer to look away |
| Look at the needleParticipant looks at the needle during vaccination | Behavioural | Look at needle and prefer to look, Look at needle and prefer to look away |
Primary outcome
Pain
Time frame: immediately after vaccination (<5 minutes)
self-reported pain assessed after vaccination using a numerical rating scale (0-10)
Fear
Time frame: immediately after vaccination (<5 minutes)
self-reported fear assessed after vaccination using a numerical rating scale (0-10)
6 secondary outcomes
Recruitment rate
Time frame: 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)
Time frame: immediately before vaccination (<5 minutes)
Duration of appointment
Time frame: immediately after vaccination
Attrition of participants
Time frame: immediately after vaccination
Preferences of participants
Time frame: immediately after vaccination (<5 minutes)
Fidelity of intervention
Time frame: During vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 35005359Mithal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Look away from the needle and Look at the needle in people with Vaccination, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Taddio, PhD (416-978-8822, anna.taddio@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: immediately after vaccination (<5 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.