Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-11 @ 6:51 AM
Study NCT ID:
NCT02937428
Status:
UNKNOWN
Last Update Posted:
2016-10-25
First Post:
2016-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Look or Not to Look at the Needle During Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-23', 'studyFirstSubmitDate': '2016-10-13', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'immediately after vaccination (<5 minutes)', 'description': 'self-reported pain assessed after vaccination using a numerical rating scale (0-10)'}, {'measure': 'Fear', 'timeFrame': 'immediately after vaccination (<5 minutes)', 'description': 'self-reported fear assessed after vaccination using a numerical rating scale (0-10)'}], 'secondaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'before vaccination (1 day to 4 weeks)', 'description': 'percentage of people eligible that participate'}, {'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)', 'description': 'percentage of individuals that prefer to look or not look at baseline'}, {'measure': 'Duration of appointment', 'timeFrame': 'immediately after vaccination', 'description': 'Amount of time taken for appointment as per clock'}, {'measure': 'Attrition of participants', 'timeFrame': 'immediately after vaccination', 'description': 'number of participants that are lost/drop-out of study'}, {'measure': 'Preferences of participants', 'timeFrame': 'immediately after vaccination (<5 minutes)', 'description': 'participant preferences about interventions according to questionnaire'}, {'measure': 'Fidelity of intervention', 'timeFrame': 'During vaccination', 'description': 'Compliance with instruction to look at the needle or look away, according to checklist'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vaccination', 'pain', 'fear', 'psychological intervention'], 'conditions': ['Vaccination']}, 'referencesModule': {'references': [{'pmid': '35005359', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* undergraduate and graduate students at the University of Toronto's Leslie Dan Faculty of Pharmacy undergoing flu vaccination\n\nExclusion Criteria:\n\n* less than 18 years of age or prior participation in the trial"}, 'identificationModule': {'nctId': 'NCT02937428', 'briefTitle': 'To Look or Not to Look at the Needle During Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'To Look or Not to Look? Pilot Study of the Effectiveness of a Simple Psychological Intervention in Reducing Vaccination Pain and Fear in Adult', 'orgStudyIdInfo': {'id': '33392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Look away and prefer to look', 'description': 'Participant who is self-identified as preferring to look at the needle is randomized to look away from the needle during vaccination', 'interventionNames': ['Behavioral: Look away from the needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Look at needle and prefer to look', 'description': 'Participant who is self-identified as preferring to look at the needle is randomized to look at the needle during vaccination', 'interventionNames': ['Behavioral: Look at the needle']}, {'type': 'EXPERIMENTAL', 'label': 'Look away and prefer to look away', 'description': 'Participant who is self-identified as preferring to look away from the needle is randomized to look away from the needle during vaccination', 'interventionNames': ['Behavioral: Look away from the needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Look at needle and prefer to look away', 'description': 'Participant who is self-identified as preferring to look away from the needle is randomized to look at the needle during vaccination', 'interventionNames': ['Behavioral: Look at the needle']}], 'interventions': [{'name': 'Look away from the needle', 'type': 'BEHAVIORAL', 'description': 'Participant looks away from the needle during vaccination', 'armGroupLabels': ['Look away and prefer to look', 'Look away and prefer to look away']}, {'name': 'Look at the needle', 'type': 'BEHAVIORAL', 'description': 'Participant looks at the needle during vaccination', 'armGroupLabels': ['Look at needle and prefer to look', 'Look at needle and prefer to look away']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3M2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Anna Taddio, PhD', 'role': 'CONTACT', 'email': 'anna.taddio@utoronto.ca', 'phone': '416-978-8822'}, {'name': 'Pamela Simmons, RN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anna Taddio', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Anna Taddio, PhD', 'role': 'CONTACT', 'email': 'anna.taddio@utoronto.ca', 'phone': '416-978-8822'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anna Taddio', 'investigatorAffiliation': 'University of Toronto'}}}}