Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT07039851
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CreativeDrama and GamificationBased
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nature Connectedness Scale', 'timeFrame': '5 minutes', 'description': 'In this study, the Nature Connectedness Scale developed by Cheng and Monroe (2012) and adapted into Turkish by Alkış Küçükaydın (2024) will be used to measure children\'s emotional and cognitive levels of connectedness to nature. The scale consists of 16 items designed to assess children\'s relationships with nature across emotional, empathic, and responsibility dimensions.\n\nThe instrument uses a five-point Likert scale: "Strongly Disagree", "Disagree", "Neutral", "Agree", and "Strongly Agree."'}, {'measure': 'The Recycling Scale for Middle School Students', 'timeFrame': '5 minutes', 'description': "The Recycling Scale for Middle School Students consists of a structure with 15 items grouped under three factors. However, one item was removed from the scale due to its standardized regression weight falling below 0.5, and Confirmatory Factor Analysis (CFA) was conducted again. As a result, the final version of the scale was confirmed to include 14 items under three dimensions: awareness, behavior, and attitude. The reliability of the scale was determined using Cronbach's Alpha, yielding a value of 0.856, indicating high internal consistency."}, {'measure': 'Demographic Information Form', 'timeFrame': '5 minutes', 'description': "The Demographic Information Form developed by the researcher will be used to collect participants' demographic characteristics and basic information regarding their environmental attitudes. This form consists of 14 questions in total. In addition to demographic data such as participants' gender, grade level, age, and parents' educational background, the form includes items about participation in school activities related to nature and the environment, use of recycling bins at home, attitudes toward spending time in nature, knowledge levels about environmental and recycling issues, types of materials separated for recycling at home, frequency of time spent in nature, emotions felt when recycling is not practiced, family recycling habits, and interest in acquiring information about nature and environmental topics.\n\nThe study data will be collected from selected middle schools affiliated with the Istanbul Directorate of National Education."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Creative drama', 'Gamification', 'Nature connectedness', 'Recycling behaviors', 'Environmental education'], 'conditions': ['Creative Drama', 'Gamification']}, 'descriptionModule': {'briefSummary': "The aim of this study is to examine the effect of a creative drama and gamification-based educational experience on children's levels of nature connectedness and recycling behaviors. With the increasing environmental problems today, instilling environmental awareness in children at an early age and helping them establish a bond with nature is of great importance for a sustainable future. In this context, creative drama stands out as an effective method in shaping environmental attitudes, as it supports children's emotional development and enhances their ability to empathize. Gamification, on the other hand, is a pedagogical strategy that increases children's active participation in learning processes and boosts their motivation.\n\nIn the study, an experimental design will be used, and a group of students will participate in an educational program themed around nature and recycling, incorporating creative drama and gamification activities. At the end of the program, children's nature connectedness and recycling behaviors will be measured, and pre-test-post-test comparisons will be made. Nature connectedness is defined as an individual's perception of nature as a whole and seeing themselves as a part of that whole, and it is strongly associated with environmentally friendly behaviors. Recycling behaviors include individuals' voluntary efforts to separate and repurpose waste.\n\nThis study aims to reveal how creative and interactive learning methods influence children's environmental awareness and behaviors, and it seeks to contribute to the development of environmental education programs.", 'detailedDescription': 'Research Design This study will be conducted using a quantitative research method within a randomized controlled experimental design, employing a pre-test and post-test approach.\n\nPopulation and Sample The study population consists of students enrolled in the 5th and 6th grades of middle schools affiliated with the Istanbul Provincial Directorate of National Education. The experimental group will receive an educational program based on creative drama and gamification, while the control group will not receive any intervention during this period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female students aged 10 to 12 years.\n\nEnrolled in 5th or 6th grade at middle schools affiliated with the Istanbul Provincial Directorate of National Education.\n\nVoluntary participation with parental consent.\n\nAble to attend all sessions and actively participate in the educational activities.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07039851', 'acronym': 'Creative Drama', 'briefTitle': 'CreativeDrama and GamificationBased', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': "Creative Drama and Gamification-Based Educational Experience: Its Effect on Children's Nature Connectedness and Recycling Behaviors", 'orgStudyIdInfo': {'id': '2025/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Creative drama and gamification sessions will be conducted under the guidance of a creative drama facilitator and will consist of four stages:\n\nWarm-up phase (10 minutes)\n\nGames and activities phase (30 minutes)\n\nImprovisation and creative participation phase (30 minutes)\n\nEvaluation and feedback phase (20 minutes)\n\nIn each session, students will be divided into different groups of equal size to promote cooperation and interaction.\n\nThe experimental group will receive training based on creative drama and gamification, while the control group will be taught using traditional instructional methods. Both groups will participate in two sessions, held once a week.\n\nThe content of the training will be structured around the themes of nature connectedness and recycling behaviors, with each session lasting approximately 90 minutes.', 'interventionNames': ['Other: Experimental']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'The control group will be taught the same topics using a traditional instructional method, without the use of creative drama or gamification elements.'}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': "Each session in the experimental group includes four phases:\n\n1. Warm-up (10 min): Students engage in ice-breakers and movement activities to relax and prepare mentally and physically.\n2. Games \\& Activities (30 min): Drama and game-based tasks related to nature and recycling promote experiential learning and teamwork.\n3. Improvisation (30 min): Students take part in role-plays and skits (e.g., acting as a tree or a recycled item) to build empathy and deepen their connection to environmental themes.\n4. Evaluation (20 min): Students reflect on their learning, share feelings, and receive feedback. Facilitators summarize key points and reinforce the session's goals.", 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nur Bahar KURU AKTÜRK', 'role': 'CONTACT', 'email': 'nurbaharkuru@arel.edu.tr'}, {'name': 'Merve KOLCU, PhD', 'role': 'CONTACT', 'email': 'merve.kolcu@sbu.edu.tr'}], 'facility': 'University of Health Sciences', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Nur Bahar KURU AKTURK, Msc', 'role': 'CONTACT', 'email': 'nurbaharkuru@gmail.com', 'phone': '05343266934'}, {'name': 'Merve KOLCU, PhD', 'role': 'CONTACT', 'email': 'merve.kolcu@sbu.edu.tr'}], 'overallOfficials': [{'name': 'Merve KOLCU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'merve.kolcu@sbu.edu.tr'}, {'name': 'Aydan YILMAZ, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'aydan.yilmaz@sbu.edu.tr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Merve Kolcu', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}