Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT05725551
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2023-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Shotblocker, Finger Puppet And Balloon Method During Intramuscular Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Fear Scale', 'timeFrame': '1 day', 'description': 'The scale is a visual measurement tool consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety) and scores between 0-4 points.The level of pain experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.'}, {'measure': 'Facial Pain Scale', 'timeFrame': '1 day', 'description': 'Graded according to the severity of the pain, the leftmost face consists of "no pain" and the rightmost face consists of a total of 6 facial expressions, such as "too much pain". Faces expressing the increase in pain intensity from left to right are scored as 0,2,4,6,8,10, respectively.The level of fear experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.'}, {'measure': 'Visual Analog Scale', 'timeFrame': '1 day', 'description': 'The scale consists of a 10 cm / 100 mm long ruler that can be used horizontally or vertically, with "no pain" at one end and "worst pain imaginable" at the other. The child is asked to mark a spot on the line that will accurately reflect his or her pain.The level of pain experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Children']}, 'descriptionModule': {'briefSummary': "The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on children's pain and fear level.", 'detailedDescription': 'The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on 7-12 age group children on pain and fear level.\n\nThe purpose of the research and all the working processes were explained to the children and parents by the researcher.\n\nChildren who met all eligibility criteria were invited to participate in the study with their parents.\n\nThe children and their parents were informed about the study, they were included in the study by announcing that they would be in one of the four groups, and this group was randomly determined.\n\nBefore starting the application, verbal and written consent was obtained from the parents of the children by reading/reading the Informed Voluntary Consent Form.\n\nThe child and parent were informed by the researcher about the pain and fear level assessment tools and application before and after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who volunteered to participate in the study and who met the inclusion criteria\n\nExclusion Criteria:\n\n* Children who did not volunteer to participate in the study'}, 'identificationModule': {'nctId': 'NCT05725551', 'briefTitle': 'The Effect of Shotblocker, Finger Puppet And Balloon Method During Intramuscular Injection', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'Three Applıed Durıng Intramuscular Injectıon In Chıldren Effect Of Dıfferent Method On Paın And Fear', 'orgStudyIdInfo': {'id': 'MU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ShotBlocker group', 'description': 'Pain in intramuscular injection It is a noninvasive, plastic tool used to reduce.', 'interventionNames': ['Device: ShotBlocker']}, {'type': 'EXPERIMENTAL', 'label': 'Finger Puppet group', 'description': 'Finger puppetry is an alternative method of interacting with the child through play while performing an intramuscular injection.', 'interventionNames': ['Other: Finger Puppet group']}, {'type': 'EXPERIMENTAL', 'label': 'Balloon group', 'description': 'Balloon inflation method, the child inflating the balloon while performing an intramuscular injection.', 'interventionNames': ['Other: Balloon group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Intramuscular injection without any intervention.'}], 'interventions': [{'name': 'ShotBlocker', 'type': 'DEVICE', 'description': 'Before the procedure, the protruding surface of the vehicle was placed on the injection site in contact with the skin and used by holding it during injection. The level of pain and fear experienced by the child during and 5 minutes after the injection was evaluated with the "Facial Expressions Pain Scale" and "Visual Comparison Scale", and the level of fear was evaluated with the "Child Fear Scale" by the child, the parent accompanying the child, and the observer.', 'armGroupLabels': ['ShotBlocker group']}, {'name': 'Finger Puppet group', 'type': 'OTHER', 'description': 'During the interaction between the finger puppet and the child, an intramuscular injection was made. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale".', 'armGroupLabels': ['Finger Puppet group']}, {'name': 'Balloon group', 'type': 'OTHER', 'description': 'An intramuscular injection was given when the child began to inflate the balloon. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale".', 'armGroupLabels': ['Balloon group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33110', 'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Mersin University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Diğdem Lafcı pHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mersin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Faculty Member,pHD', 'investigatorFullName': 'Didem Lafci', 'investigatorAffiliation': 'Mersin University'}}}}