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{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-13', 'releaseDate': '2025-04-28'}], 'estimatedResultsFirstSubmitDate': '2025-04-28'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Student Satisfaction and Confidence in Learning', 'timeFrame': '2 weeks later', 'description': 'For the pre-test data, the students were given the "Individual Introduction Form" and the "Student Satisfaction and Confidence in Learning Scale" and asked to fill them in.\n\nAt the end of the 2nd week, the "Student Satisfaction and Confidence in Learning Scale" was applied again to evaluate the satisfaction and self-confidence of the students who received training with different teaching methods for 2 weeks.\n\nThe Student Satisfaction and Confidence in Learning Scale was developed to measure the satisfaction and self-confidence of nursing students who experience learning with simulation method. The Turkish validity and reliability study of the scale was conducted by Karaçay and Kaya in 2015. The scale consists of a total of 13 items and 2 sub-dimensions (satisfaction with learning and self-confidence). A score between 13-65 can be obtained from the scale developed in 5-point Likert type. A high score on the scale indicates high \'student satisfaction and self-confidence\'.'}, {'measure': 'Effect of Perceived Stress', 'timeFrame': '2 weeks later', 'description': 'For the pre-test data, the students were given the "Perceived Stress Scale for Nursing Students" and asked to fill them in.\n\nAt the end of the 2nd week, the "Perceived Stress Scale for Nursing Students" was applied again to evaluate the stress of the students who received training with different teaching methods for 2 weeks. The Perceived Stress Scale for Nursing Students was developed to determine the level and type of stress perceived by nursing students in clinical practice. Turkish validity and reliability study was conducted in 2015. The scale consists of a total of 29 items and 6 sub-dimensions. A score between 0-116 can be obtained from the scale developed in 5-point Likert type. A high score on the scale indicates a high degree of stress.'}, {'measure': 'Effect of psychomotor skills', 'timeFrame': '2 weeks later', 'description': "In order to evaluate the psychomotor skill level of the students in the groups, the researcher and the independent observer evaluated the drug administration skills of each student individually and filled out the 'Psychomotor Skill Assessment Checklists for Drug administration'. The skill evaluation process of each student lasted 10-15 minutes.\n\nSkill checklists were developed to evaluate the skill performance of students on urinary system applications. Skill checklists are step-by-step checklists showing the skills expected to be performed by students and were prepared by reviewing the relevant current literature."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing students', 'Serious Game', 'Psychomotor Skills', 'Stress', 'Video-Assisted Learning'], 'conditions': ['Nursing Students']}, 'descriptionModule': {'briefSummary': 'Aim: This study was conducted to evaluate the effect of a serious game and video-assisted training program developed for parenteral drug administration education on nursing students\' psychomotor skill development, perception of clinical stress, satisfaction, and self-confidence in learning.\n\nMaterial and Method: The study was carried out as a randomized controlled experimental research design between June 2023 and April 2025 at the Faculty of Nursing, İnönü University. All students enrolled in the Nursing Department during the Spring Semester of the 2023-2024 academic year constituted the study population. The sample consisted of 99 students (33 in the serious game group, 33 in the video group, and 33 in the control group), determined by power analysis. Data were collected using the "Psychomotor Skills Evaluation Checklists," the "Perceived Stress Scale for Nursing Students," and the "Student Satisfaction and Self-Confidence in Learning Scale."', 'detailedDescription': "Serious games help to develop participants' problem solving, critical thinking and communication skills, while enriching the learning experience. Serious gaming is a learning-first approach that mimics reality using virtual simulation. These games can be used to optimise the acquisition of clinical skills, stimulate student motivation by completing the simulation and allow teachers to assess students' progress.Video-assisted learning provides learners with a visual tool that facilitates the understanding of abilities and skills. It is often used to illustrate how a teacher or expert addresses a topic, process or skill. The content can then be followed, learnt and applied by learners. In this study, both methods were evaluated together and their effects on the development of nursing students' competencies for parenteral drug adminstrantion practices were evaluated"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a 1st year nursing student,\n* Receiving training on parenteral drug applications for the first time,\n* Not having any physical disabilities related to vision, hearing and motor skills,\n* Having a smart mobile phone with Android/IOS operating system, and\n* Volunteering to participate in the study.\n\nExclusion Criteria:\n\n* Students who made vertical transfer to the department with DGS because they may have taken the subject of parenteral drug applications in an associate degree programme before,\n* Students who did not have a smart mobile phone with Android / IOS operating system and\n* Students who did not volunteer to participate in the study were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06947005', 'briefTitle': 'The Effect of Serious Game and Video-Assisted Education on Nursing Students', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': "The Effect of Serious Game and Video-Assisted Education on Nursing Students' Psychomotor Skill Development, Perception of Clinical Stress, Satisfaction and Self-Confidence in Learning", 'orgStudyIdInfo': {'id': 'Tülay Çetkin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Serious game group', 'interventionNames': ['Behavioral: Intervention 1']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention 2', 'description': 'Video asisted learning group', 'interventionNames': ['Behavioral: Intervention 2']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control'}], 'interventions': [{'name': 'Intervention 1', 'type': 'BEHAVIORAL', 'otherNames': ['Serious game'], 'description': 'The students in the serious game group were asked to download the drug applications serious game to their phones. They were asked to play the game for two weeks. The students continued to play the game at any time and as often as they wanted until they won at least one gold medal for each application. At the end of the 2nd week, a questionnaire form and VAS scale were applied to the students to evaluate the post-test data and their satisfaction levels with the game. The collected data were analysed to understand the different dimensions of game satisfaction and to assess overall satisfaction levels.', 'armGroupLabels': ['Intervention']}, {'name': 'Intervention 2', 'type': 'BEHAVIORAL', 'otherNames': ['Video assited learning'], 'description': 'A WhatsApp group was established to maintain communication with the students in the video-supported education group. After the pre-test data were collected, the students were introduced to the ed-puzzle web page where they could watch the application videos and were asked to register to the system. No fee was paid to register to the ed-puzzle web page. Students were given the opportunity to watch the videos on the ed-puzzle web page for 2 weeks and answer the questions. Each student was allowed to watch the videos at least once until they answered all the questions correctly. The number of videos watched was monitored by the researcher. At the end of the 2nd week, post-test data were collected from the students.', 'armGroupLabels': ['Intervention 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu University', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Hakime Aslan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hakime Aslan', 'investigatorAffiliation': 'Inonu University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-04-28', 'type': 'RELEASE'}, {'date': '2025-05-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hakime Aslan, Principal Investigator, Inonu University'}}}}