Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT05672303
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2023-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain During Vaccine Administration
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain level will be measured in the premature baby', 'timeFrame': '15 minutes', 'description': 'PIPP-R Form: The PIPP scale, developed by Stevens et al. in 1996, is a validated assessment tool used to evaluate acute pain experienced by preterm infants during interventional procedures (Stevens et al., 1996). This scale was revised by Stevens et al. in 2014 (Stevens et al., 2014). The PIPP-R was adapted into Turkish in 2019 (Taplak, \\& Bayat, 2019). PIPP-R consists of behavioral subscales such as frowning, squeezing eyes, nasolabial furrow, physiological and behavioral status including heart rate and SPO2, and contextual subscales such as gestational age.'}], 'secondaryOutcomes': [{'measure': 'Crying time', 'timeFrame': '15 minutes', 'description': 'Crying time will be evaluated in seconds with a coronometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant, Newborn, Pain']}, 'descriptionModule': {'briefSummary': 'Many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. In neonatal care and reduction of acute interventional pain; Non-pharmacological methods including behavioral, psychological and environmental regulations should be used.\n\nIn the hepatitis B vaccine administered to preterm babies, stimulating the grasping reflex can make the preterm baby feel safe and calm. In the literature, there are many studies aimed at reducing pain in preterm newborns. However, no study has been found on the effect of grasping reflex stimulation on pain and crying in hepatitis B vaccine administration to preterm infants.\n\nThis study was planned to examine the effect of grasping reflex on pain and crying duration in preterm infants with hepatitis B vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 28-36 gestational week\n* No congenital malformation\n* follow up with a diagnosis of respiratory distress syndrome,\n* receive oxygen support with a nasal cannula or tube,\n* not receive mechanical ventilation support,\n* no contraindications for hepatitis B vaccine administration,\n* stable vital signs before vaccination,\n* not receive analgesic sedation treatment\n* whose parents give verbal and written consent to participate in the study.\n\nExclusion Criteria:\n\n* Infants of parents who did not give informed voluntary consent will not be included in the study.\n* Decreased oxygen saturation levels\n* Tachycardia just before the vaccine administration\n* Invasive intervention in the right hand.'}, 'identificationModule': {'nctId': 'NCT05672303', 'briefTitle': 'Pain During Vaccine Administration', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of Grasp Reflex Stimulation on Pain During Vaccine Administration', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00/277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine procedure will be applied'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Palmar grasp reflex will be stimulated with routine procedure.', 'interventionNames': ['Behavioral: Palmar grasp reflex']}], 'interventions': [{'name': 'Palmar grasp reflex', 'type': 'BEHAVIORAL', 'description': "The reflex can be stimulated by moving an object distally across the palm. In the study, at the beginning of the vaccine administration, the right hand of the infant will be moved distally along the palm with the researcher's index finger, thus providing reflex stimulation.", 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25040', 'city': 'Yakutiye', 'state': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Türkan Kadiroğlu', 'geoPoint': {'lat': 39.89821, 'lon': 41.26916}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MSc Elif Simay KOÇ', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pricipal Investigator', 'investigatorFullName': 'Türkan Kadiroğlu', 'investigatorAffiliation': 'Ataturk University'}}}}