Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:28 PM
Study NCT ID:
NCT07455305
Status:
COMPLETED
Last Update Posted:
2026-03-06
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Simultaneous Versus Sequential Intramuscular Vaccine Injections on Pain Levels in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All assessments were performed by the same experienced pediatric nurse who was not part of the research team and was unaware of the study hypotheses.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain was assessed using the FLACC', 'timeFrame': 'Time Frame: Baseline; During injection (periprocedural); Immediately after injection (within 1 minute)', 'description': 'The scale has 5 behavioral assessment categories (facial expression, leg movement, activity, crying, consolability). Each category consists of three items and is scored between 0 and 2 points. The total scale score ranges from 0 to10, with higher scores indicating greater pain intensity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sequential injection', 'simultaneous injection'], 'conditions': ['Injection Pain Prevention', 'Injection Pain']}, 'descriptionModule': {'briefSummary': 'This study was designed as a randomized controlled trial comparing simultaneous and sequential administration of intramuscular vaccines in infants.', 'detailedDescription': 'The study was carried out in the pediatric outpatient vaccination clinic of a private hospital in Istanbul, Türkiye, between 1 September and 15 November 2021.\n\nInfants were eligible if they were younger than 12 months, required two routine intramuscular vaccines during the same visit, and were accompanied by a parent or legal guardian able to provide informed consent.\n\nInfants were excluded if they had received analgesics within six hours prior to vaccination, received vaccines other than hepatitis B, pentavalent combination vaccine (DTaP-IPV/Hib), or pneumococcal conjugate vaccine, or had known neurological, developmental, or motor impairments.\n\nInfants were randomly assigned in a 1:1 ratio to either the simultaneous injection group or the sequential injection group using computer-generated randomization (www.randomizer.org). Allocation was completed prior to the vaccination procedure.\n\nA total of 150 infants were assessed for eligibility; 40 did not meet inclusion criteria. The final sample included 110 infants (55 per group). No participants were lost to follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The following criteria were determined: the child was ordered to receive two of the routine childhood IM vaccines (hepatitis B, quintuple combination vaccine, pneumococcal vaccine), the parents were willing to participate in the study, the child had not received painkillers in the last 6 hours, and the child did not have mental and motor retardation.\n\nExclusion Criteria:\n\n* It was determined that the child should be 1 year of age or older, the vaccines other than the quintuple mixed vaccine, Pneumococcal vaccine and Hepatitis B vaccine should have been ordered by the physician.'}, 'identificationModule': {'nctId': 'NCT07455305', 'briefTitle': 'The Effect of Simultaneous Versus Sequential Intramuscular Vaccine Injections on Pain Levels in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Effect of Simultaneous Versus Sequential Intramuscular Vaccine Injections on Pain Levels in Infants: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IUCerrahpasaRCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simultaneous injection group', 'description': 'Two trained pediatric nurses administered the vaccines simultaneously into different thighs (vastus lateralis muscles) following a coordinated countdown.', 'interventionNames': ['Other: Simultaneous injection']}, {'type': 'OTHER', 'label': 'Sequential injection group', 'description': 'A single nurse administered the two vaccines consecutively into different thighs. A pause of approximately 10-15 seconds between injections allowed the infant to settle.\n\nVaccinations were performed individually in a quiet room to prevent distraction or distress from other children. Infants were positioned on an examination stretcher with the thigh exposed.', 'interventionNames': ['Other: Sequential injection']}], 'interventions': [{'name': 'Simultaneous injection', 'type': 'OTHER', 'description': 'Two trained pediatric nurses administered the vaccines simultaneously into different thighs (vastus lateralis muscles) following a coordinated countdown.', 'armGroupLabels': ['Simultaneous injection group']}, {'name': 'Sequential injection', 'type': 'OTHER', 'description': 'A single nurse administered the two vaccines consecutively into different thighs. A pause of approximately 10-15 seconds between injections allowed the infant to settle.', 'armGroupLabels': ['Sequential injection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'state': 'İ̇stanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Koç University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Sevil Inal', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Institutional policy does not allow'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'IstanbulUC', 'investigatorFullName': 'Sevil Inal', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}