Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 4:27 PM
Study NCT ID:
NCT06994104
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Effects of Smartphone and Game Addiction on Activity, Sleep, Stress, and Pain in Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082424', 'term': 'Internet Addiction Disorder'}, {'id': 'D000088942', 'term': 'Technology Addiction'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 193}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smartphone Addiction Level Measured by SAS-SF', 'timeFrame': 'At enrollment', 'description': "The Smartphone Addiction Scale-Short Form (SAS-SF) is a 10-item self-report instrument scored on a 6-point Likert scale (1 = Strongly disagree, 6 = Strongly agree). The total score ranges from 10 to 60, with higher scores indicating higher levels of smartphone addiction. The Turkish version of the scale has shown high reliability (Cronbach's α = 0.88). All participants will complete the questionnaire online or in print."}, {'measure': 'Digital Game Addiction Level Measured by DGAS-U', 'timeFrame': 'At enrollment', 'description': 'The Digital Game Addiction Scale for University Students (DGAS-U) consists of 21 items rated on a 5-point Likert scale (1 = Never, 5 = Always). Total scores range from 21 to 105, with higher scores indicating greater digital game addiction. The scale has demonstrated strong psychometric properties in university populations. In this study, the questionnaire will be completed online or in paper form.'}], 'secondaryOutcomes': [{'measure': 'Physical Activity Level Assessed by IPAQ-Short Form', 'timeFrame': 'At enrollment', 'description': 'The International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to assess the physical activity level over the last 7 days. It includes questions on walking, moderate and vigorous activities, and sitting time. Results are expressed in MET-min/week; higher values indicate greater physical activity.'}, {'measure': 'Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'At enrollment', 'description': 'Sleep quality over the past month will be measured using the PSQI, which includes 19 items grouped into 7 components (e.g., duration, latency, disturbances). The global score ranges from 0 to 21; scores \\>5 indicate poor sleep quality.'}, {'measure': 'Perceived Stress Measured by Perceived Stress Scale (PSS)', 'timeFrame': 'At enrollment', 'description': "The PSS-10 will be used to evaluate participants' perceived stress levels over the past month. It contains 10 items rated on a 5-point Likert scale (0-4), with total scores ranging from 0 to 40. Higher scores indicate greater perceived stress."}, {'measure': 'Fatigue Level Measured by Multidimensional Fatigue Inventory (MFI-20)', 'timeFrame': 'At enrollment', 'description': 'Fatigue will be assessed with the MFI-20, a 20-item instrument measuring five dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each item is scored on a 5-point Likert scale, total score ranging from 20 to 100. Higher scores indicate more fatigue.'}, {'measure': 'Pain Intensity Measured by Numeric Rating Scale (NRS)', 'timeFrame': 'At enrollment', 'description': 'Pain intensity in specific anatomical regions (e.g., neck, back, shoulder, elbow, wrist) will be rated using the NRS. Participants score their current pain from 0 (no pain) to 10 (worst possible pain). Widely used in clinical and survey research.'}, {'measure': 'Musculoskeletal Discomfort Measured by Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)', 'timeFrame': 'At enrollment', 'description': 'CMDQ assesses discomfort frequency, severity, and functional interference for over 20 body regions. Participants report symptoms experienced in the past 7 days. Higher scores reflect greater musculoskeletal impact. The tool is validated for use in ergonomic and student populations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartphone addiction', 'Digital game addiction', 'Physical activity', 'Sleep quality', 'Stress', 'Fatigue', 'Musculoskeletal pain', 'University students', 'Self-reported questionnaire', 'Screen time'], 'conditions': ['Smartphone Addiction', 'Game Addiction, Video', 'Musculoskeletal Pain Disorder', 'Sleep', 'Fatigue Symptom', 'Inactivity, Physical']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the relationship between smartphone and digital game addiction and various health indicators, including physical activity level, sleep quality, stress, fatigue, and musculoskeletal pain among young people. University students often spend prolonged time on digital devices, which may affect their mental and physical well-being. By collecting self-reported data through validated questionnaires, the study will explore how these addictive behaviors are associated with lifestyle and health outcomes. The findings may help guide future interventions to promote healthier technology use among youth.', 'detailedDescription': "This cross-sectional, observational study investigates the associations between smartphone and digital game addiction and physical activity level, sleep quality, perceived stress, fatigue, and musculoskeletal pain among undergraduate students in the Department of Physiotherapy and Rehabilitation at Istanbul University-Cerrahpaşa. The study targets a minimum of 193 participants, with sample size determined via G\\*Power analysis. Data will be collected using online survey forms distributed to students who provide informed consent.\n\nThe study employs a range of validated assessment tools including the Smartphone Addiction Scale-Short Form (SAS-SF), Digital Game Addiction Scale for University Students (DGAS-U), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), Multidimensional Fatigue Inventory (MFI-20), Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), and the Numerical Rating Scale (NRS) for pain intensity. Sociodemographic data and screen usage patterns will also be gathered.\n\nStatistical analysis will be conducted using IBM SPSS Statistics (Version 24). Appropriate statistical tests such as correlation analysis, independent samples t-test or Mann-Whitney U test, ANOVA or Kruskal-Wallis test, and multiple regression analysis will be applied to assess relationships and differences among subgroups. Comparisons will be made based on variables such as gender, academic year, screen time, and addiction severity.\n\nThis study is expected to reveal important links between digital addiction and decreased physical activity, poor sleep quality, elevated stress levels, fatigue, and increased musculoskeletal pain, particularly in the neck, back, shoulder, elbow, and wrist. It offers a comprehensive evaluation of both psychosocial and physical health outcomes related to digital addiction in physiotherapy students, a population with future responsibilities in musculoskeletal health care.\n\nBy highlighting the potential occupational health risks associated with students' digital habits, the study underscores the importance of preventive strategies, including ergonomics education, digital health literacy, and self-care practices. It also contributes uniquely to the literature by addressing how prolonged device use relates to musculoskeletal symptoms and by examining how daily step counts and physical activity levels may be influenced by digital addiction. Ultimately, the findings are expected to inform future interventions aimed at promoting healthier digital behaviors and supporting the well-being of students in health-related academic programs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be selected from undergraduate students enrolled in physiotherapy and rehabilitation programs at a health sciences faculty in an urban university setting. The population represents young adults aged 18 to 30 years with regular access to smartphones and/or digital games. Participants will be recruited through voluntary participation in response to announcements distributed via institutional communication channels.', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria Aged between 18 and 30 years Currently enrolled as a student in a physiotherapy and rehabilitation undergraduate program Willing to voluntarily participate and able to provide signed informed consent Capable of providing self-reported data regarding smartphone or digital game use\n* Exclusion Criteria Diagnosis of any neurological, psychiatric, or chronic pain disorder Presence of a serious musculoskeletal condition or a history of major orthopedic surgery Having a medical condition (e.g., sleep disorder) that could affect the study outcomes Previous participation in a treatment program for smartphone or digital game addiction'}, 'identificationModule': {'nctId': 'NCT06994104', 'briefTitle': 'Exploring the Effects of Smartphone and Game Addiction on Activity, Sleep, Stress, and Pain in Youth', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Association of Smartphone and Digital Game Addiction With Physical Activity, Sleep Quality, Stress, Fatigue, and Musculoskeletal Pain in University Students: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'iucbp25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Physiotherapy Students', 'description': 'Participants are undergraduate students enrolled in the Department of Physiotherapy and Rehabilitation. All participants complete the same set of self-reported questionnaires assessing smartphone and digital game addiction, physical activity, sleep quality, stress, fatigue, and musculoskeletal pain.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Marmara', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ayse Zengin Alpozgen, Asst. Prof.', 'role': 'CONTACT', 'email': 'azengin@istanbul.edu.tr', 'phone': '+90(212)8663700'}], 'facility': 'Istanbul University Cerrahpasa, Faculty of Health Science', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ayşe Zengin Alpözgen, Assoc. Prof.', 'role': 'CONTACT', 'email': 'azengin@iuc.edu.tr', 'phone': '+90 552 683 0479'}, {'name': 'Ayşe Zengin Alpözgen, Assoc. Prof.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Ayşe Zengin Alpözgen, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data (IPD) because the study involves self-reported questionnaire data collected from healthy volunteers and does not include clinical interventions or sensitive health data requiring broader dissemination.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Ayse Zengin Alpozgen', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}