Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-04 @ 7:38 PM
Study NCT ID:
NCT06497166
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2024-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining of Occupational Balance, Executive Functions, and Quality of Life of Adolescents with Internet Gaming Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082424', 'term': 'Internet Addiction Disorder'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D000088942', 'term': 'Technology Addiction'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adolescent Occupational Balance Scale', 'timeFrame': 'Baseline', 'description': 'The scale measures occupational balance. According to the four-point Likert rating, the lowest raw score to be taken from the scale is 27, and the highest raw score is 108. It takes approximately 15-20 min to respond to the whole scale. A high score obtained from the scale indicates a high level of occupational balance.'}, {'measure': 'Teenage Executive Functioning Inventory', 'timeFrame': 'Baseline', 'description': 'The scale measures executive functioning. It is a 5-point Likert type inventory and includes statements scored from 1 to 5 (1: Definitely not true, 5: Definitely true). Higher scores represent more difficulty with executive functions. The lowest score to be taken from the scale is 20, and the highest score is 100.'}, {'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': 'Baseline', 'description': 'The scale measures quality of life. It is a 23-item measurement tool. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate better quality of life. This instrument yields a Total score, Physical Health Summary score (Equivalent to the Physical Functioning subscale) and Psychosocial Health Summary score (Based on the Emotional Functioning subscale, Social Functioning subscale, and School Functioning subscale). The lowest score to be taken from the scale is 0, and the highest score is 100.'}, {'measure': 'Internet Gaming Disorder Scale', 'timeFrame': 'Baseline', 'description': 'The scale measures internet gaming disorder severity. The lowest score that can be obtained from the scale is 20 and the highest score is 100. Higher scores indicate a more severe disorder.'}, {'measure': 'Sociodemographic Information Form', 'timeFrame': 'Baseline', 'description': 'Measures sociodemographic information'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Addiction', 'Executive functions', 'Internet gaming disorder', 'Occupational balance', 'Quality of life'], 'conditions': ['Internet Addiction Disorder']}, 'descriptionModule': {'briefSummary': 'Internet gaming disorder leads to social problems and isolation, neglect of daily responsibilities, behavioral disorders, and cognitive and physical impairments. It is thought that assessing the occupational profiles and cognitive functions of adolescents with internet gaming disorder will bring a new perspective to the occupational therapy literature. The aim of the present study is to examine the occupational balance, executive functions, and quality of life of adolescents with internet gaming disorder.', 'detailedDescription': 'The study, planned to be conducted with individuals aged 12-18 who are followed up in the Child and Adolescent Mental Health and Diseases outpatient clinic of Bezmialem Vakif University and diagnosed with internet gaming disorder according to DSM-V diagnostic criteria, will include a total of 62 participants, with 31 in the study group and 31 in the healthy control group. All individuals who provide written consent will be administered the Sociodemographic Data Form, Internet Gaming Disorder Scale, Teenage Executive Function Inventory, Pediatric Quality of Life Inventory-Adolescent Form, and Adolescent Occupational Balance Scale, and the results will be recorded. The obtained results will be statistically analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents diagnosed with internet gaming disorder', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Internet Gaming Disorder\n* Aged between 12 and 18\n* Proficiency in Turkish\n* Open to communication and cooperation\n* Willing to participate in the study\n* No reported cognitive impairment\n\nExclusion Criteria:\n\n* Additional psychiatric diagnosis\n* Having a neurological problem that would impair communication and collaboration'}, 'identificationModule': {'nctId': 'NCT06497166', 'briefTitle': 'Examining of Occupational Balance, Executive Functions, and Quality of Life of Adolescents with Internet Gaming Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Examining of Occupational Balance, Executive Functions, and Quality of Life of Adolescents Diagnosed with Internet Gaming Disorder', 'orgStudyIdInfo': {'id': 'BEZMIALEM-BDEMIRCI-2024-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Research Group', 'description': '12-18 year old adolescents diagnosed with internet gaming disorder'}, {'label': 'Control Group', 'description': '12-18 year old healthy adolescents'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Beyzanur Demirci, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Beyzanur Demirci', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}