Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
Study NCT ID:
NCT04420559
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2020-06-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intramuscular Benzathine Penicillin Injection Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007273', 'term': 'Injections, Intramuscular'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale for pain measurement', 'timeFrame': '4 months', 'description': '(Minimum score: 0 ; Maximum score:10) Higher scores mean a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale for satisfaction measurement (Minimum score: 0 ; Maximum score:10)', 'timeFrame': '4 months', 'description': '(Minimum score: 0 ; Maximum score:10) Higher scores mean a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Injection Site Discomfort']}, 'referencesModule': {'references': [{'pmid': '33608955', 'type': 'DERIVED', 'citation': 'Basak T, Demirtas A, Yorubulut SM. Virtual reality and distraction cards to reduce pain during intramuscular benzathine penicillin injection procedure in adults: A randomized controlled trial. J Adv Nurs. 2021 May;77(5):2511-2518. doi: 10.1111/jan.14782. Epub 2021 Feb 19.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study was the determination of the effect of applying VR and DC distraction methods on patients' pain and satisfaction levels during IM benzathine penicillin injection.\n\nThe research hypothesis:\n\n1. Are Virtual Reality and Distraction Card effective in reducing pain due to injection of IM benzathine penicillin?\n2. Does the use of Virtual Reality and Distraction Card during the injection process of IM benzathine penicillin have an effect on patient satisfaction?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* agree to participate in the research,\n* being over the age of 18,\n* being native speaker,\n* not having vision and hearing problems,\n* being prescribed benzathine penicillin with a dose of 1.200.000 IU,\n* being experienced of IM injection,\n* not having IM injection for the last 1 month\n\nExclusion Criteria:\n\n* volunteers who have scar, incision, lipodystrophy, abscess, necrosis, hematoma, ecchymosis, infection, pain and paralysis at the VG site\n* volunteers are excluded if the injection process cannot be performed at one time'}, 'identificationModule': {'nctId': 'NCT04420559', 'briefTitle': 'Intramuscular Benzathine Penicillin Injection Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Use of Virtual Reality and Distraction Cards to Reduce Pain During Intramuscular Benzathine Penicillin Injection Procedure in Adults: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '18/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'interventionNames': ['Other: Intramuscular Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Distraction Card', 'interventionNames': ['Other: Intramuscular Injection']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Intramuscular Injection', 'type': 'OTHER', 'description': 'Intramuscular Benzathine Penicillin Injection Procedure', 'armGroupLabels': ['Distraction Card', 'Virtual Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Tulay Basak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Fundamentals of Nursing Department', 'investigatorFullName': 'Tulay Basak', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}