Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:34 AM
Study NCT ID:
NCT07379034
Status:
COMPLETED
Last Update Posted:
2026-01-30
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of ShotBlocker and Vibration on Pain During Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLACC Scale', 'timeFrame': 'up to 6 months', 'description': 'The FLACC score will be used as the data collection tool. The FLACC scale is a valid and reliable measure that assesses infant pain by evaluating five domains-facial expression, leg movement, activity level, crying, and consolability-and scores pain on a scale from 0 to 10.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaccination', 'pain', 'infant', 'Shotblocker', 'Vibration'], 'conditions': ['Vaccination', 'Pain', 'Infant', 'Shotblocker', 'Vibration']}, 'descriptionModule': {'briefSummary': 'This study was conducted to investigate the effects of ShotBlocker and a vibration pen on pain in infants during routine vaccination. In this randomized controlled trial, 96 healthy infants aged 2-6 months were included. The infants were randomized into three groups: vibration pen, ShotBlocker, and control. Pain was assessed before, during, and after the procedure using the FLACC scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infant aged 2-6 months\n* Written consent from the parent\n\nExclusion Criteria:\n\n* Premature infants born before 37 weeks\n* Infants with severe neurodevelopmental disorders\n* Presence of acute infection or fever\n* History of a previous serious vaccine reaction'}, 'identificationModule': {'nctId': 'NCT07379034', 'briefTitle': 'The Effect of ShotBlocker and Vibration on Pain During Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of ShotBlocker and Vibration Pen on Pain During Vaccination in Healthy Infants: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Research1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental 1', 'description': 'ShotBlocker Group', 'interventionNames': ['Other: ShotBlocker Group']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 2', 'description': 'Vibration device group', 'interventionNames': ['Other: Vibration Group']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine nursing care'}], 'interventions': [{'name': 'ShotBlocker Group', 'type': 'OTHER', 'description': "ShotBlocker is a plastic medical device with multiple blunt projections that is applied by pressing on the skin during injection. It aims to reduce pain transmission through activation of the Gate Control Theory by stimulating multiple sensory nerve endings and diverting the infant's attention from the painful stimulus.", 'armGroupLabels': ['Experimental 1']}, {'name': 'Vibration Group', 'type': 'OTHER', 'description': 'The vibration pen is a battery-operated device that delivers high-frequency mechanical vibrations and is applied near the injection site. It aims to reduce perceived pain intensity by stimulating large-diameter nerve fibers and inhibiting pain transmission at the "gate" level.', 'armGroupLabels': ['Experimental 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Yakutiye', 'state': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.89821, 'lon': 41.26916}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Sümeyye EKİCİ', 'investigatorAffiliation': 'Ataturk University'}}}}