Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT04464018
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2020-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse,Intramuscular Injection, Hybrid Simulation
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': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled experimental study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2020-07-04', 'studyFirstSubmitQcDate': '2020-07-04', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intramuscular Injection Achievement Test', 'timeFrame': 'This test was administered 3 times. before the theoretical subject is explained, after the theoretical subject is explained and after the hybrid simulation is applied', 'description': 'This test contains 21 multiple choice questions, including IM injection application topics.'}, {'measure': 'Intramuscular Injection Application Skill Assessment Form', 'timeFrame': 'This test was administered 1 time. applied after hybrid simulation', 'description': 'The IM injection application skill assessment form consists of 39 application steps. the total was calculated over 100 points.'}, {'measure': 'Two Column Writing Reflective Thinking Strategies', 'timeFrame': 'This test was administered 1 time. applied after hybrid simulation', 'description': 'In the case of two-column text used in this research, the page is divided horizontally in the middle. Two questions were asked on the left and right side of the page.'}, {'measure': 'Scale of Student Satisfaction and Self-confidence in Learning', 'timeFrame': 'This test was administered 1 time. applied after hybrid simulation', 'description': 'It consists of two sub-dimensions," satisfaction with learning "and" self-confidence", and a total of 13 items.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intramuscular injection', 'hybrid simulation'], 'conditions': ['Educational Problems']}, 'referencesModule': {'references': [{'pmid': '26852426', 'type': 'BACKGROUND', 'citation': 'Uys Y, Treadwell I. Using a simulated patient to transfer patient-centred skills from simulated practice to real patients in practice. Curationis. 2014;37(1):e1-e6. doi: 10.4102/curationis.v37i1.1184. Epub 2014 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'The study was conducted as a randomized controlled experimental study in order to determine the effect of hybrid simulation training on gaining the intramuscular injection skills of nursing students. The sample of the study consisted of 126 students (63 study groups, 63 control groups) enrolled in Nursing Principles Course at Pamukkale University Faculty of Health Sciences in 2018-2019 academic year. In the study, the study group performed hybrid simulation (standard patient+Digital half hip model simulator) and the control group performed simulation with low reality simulation method (hip/intramuscular model). Study data were collected using Student Identification Form, Intramuscular Injection Achievement Test, Intramuscular Injection Application Skill Assessment Form, Two Column Writing Reflective Thinking Strategies and Scale of Student Satisfaction and Self-confidence in Learning.', 'detailedDescription': "Nursing students need to be proficient in nursing knowledge and skills before entering a health care environment in order to provide safe care to patients. One of the important and difficult to accomplish skills that nursing students must learn is the ability to administer intramuscular injections. In order to avoid complications due to IM injection application, it is necessary to comply with surgical asepsia, to know the method of application correctly and to have psychomotor skills. Therefore, nursing students are expected to graduate with knowledge and skills related to IM injection application during their education. Basic plastic mannequins without advanced technology, mannequins or models with low technological features that present the selected anatomical parts of the human body can also be used in standard patient and hybrid simulation. Hybrid simulation applications contribute to learners ' ability to develop psychomotor skills in a safe and realistic environment, as well as problem solving, critical thinking and decision making. Furthermore, hybrid simulations have become an ethical requirement to improve students ' skills without causing any potential harm to actual patients. In this study, the effectiveness of HS method will be evaluated to gain IM injection skills in nursing students. It will be ensured that the students ' knowledge and skills will be sufficient by increasing their desire to learn about IM injection, where they experience intense fear and anxiety before going to the clinic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students who have not received IM injection skills training before,\n* who have no clinical experience,\n* who have accepted to participate in the research\n\nExclusion Criteria:\n\n* Students who have received IM injection skills training before,\n* who have clinical experience,'}, 'identificationModule': {'nctId': 'NCT04464018', 'briefTitle': 'Nurse,Intramuscular Injection, Hybrid Simulation', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'The Effect of Hybrid Simulation in the Development of Intramuscular Injection Skills of Nursing Students', 'orgStudyIdInfo': {'id': '60116787-020/4308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Working group', 'description': 'Working group (hybrid simulation method) after the theoretical lecture, the application with hybrid simulation method is made by videotaping. Repeat the same practice after 1 Week', 'interventionNames': ['Other: working grup']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group (Low reality simulation method) after the theoretical lecture, the application with low reality simulation method is made. Repeat the same practice after 1 Week Control group received only general care'}], 'interventions': [{'name': 'working grup', 'type': 'OTHER', 'description': 'After each student received theoretical training, they performed an intravenous injection on the model. In the study group performed hybrid simulation. After finishing the simulation application. the students went to the analysis room and watched their own application videos. The analysis session was held immediately after all the students in the group completed their applications.The IM injection success Test and Student Satisfaction and self-confidence scale were applied to the study and control groups after the laboratory application was completed.', 'armGroupLabels': ['Working group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'state': 'Pamukkale Universty Hospital', 'country': 'Turkey (Türkiye)', 'facility': 'Turkey', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'arife şanlıalp zeyrek, pHd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant researcher'}, {'name': 'nevin kuzu kurban, prof. dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'responsible researcher'}]}, 'ipdSharingStatementModule': {'url': 'https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Findings can be shared after the study has been published.', 'ipdSharing': 'YES', 'description': 'Study results will be announced in a publication', 'accessCriteria': 'The sociodemographic characteristics of the participants, the test findings including the answers to the research questions and statistical analyzes will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prelector', 'investigatorFullName': 'Arife Şanlıalp Zeyrek', 'investigatorAffiliation': 'Pamukkale University'}}}}