Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT06953102
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2025-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Association of Anxiety and Sleep Disturbances Among Medical Students.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-29', 'size': 99532, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-29T12:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Sleep Disturbances', 'timeFrame': '1 month', 'description': "The Pittsburgh Sleep Quality Index (PSQI) has been used to assess the pattern and the quality of sleep.\\[8\\] This questionnaire assesses sleep quality over a 1-month time interval based on self-report by the participant. PSQI differentiates 'Poor' from 'Good' sleep by measuring Seven Domains: Subjective Sleep Quality, Latency, Sleep Duration, Sleep Efficiency, Disturbances, Medication, and Daytime Dysfunction over the last month. The measure consists of 19 individual items, creating 7 components that produce one global score and take 5-10 minutes to complete."}, {'measure': 'Assessment of Anxiety', 'timeFrame': '1 month', 'description': 'To assess Anxiety, the Beck Anxiety Inventory (BAI)\\[9\\] has been used. This scale is a self-report measure of anxiety in children and adults, which asks the subject to rate 21 items on a scale of 0-3. The questions used in this measure ask the subject about common symptoms of anxiety that the subject had had during the past week. It is designed for individuals aged 17 and above and takes 5-10 minutes to complete. The total score is calculated by the standard mean of the responses to the 21 items. A score of 0-21 = low anxiety. A score of 22-35 = moderate anxiety. A Score of 36 and above signifies potentially concerning levels of anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep disturbances.', 'Anxiety', 'Medical students', 'Pittsburgh Sleep Quality Index (PSQI)', 'Beck Anxiety Inventory (BAI)', 'Sleep quality'], 'conditions': ['Sleep Disturbances', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Observational, Cross-sectional study', 'detailedDescription': 'It was a cross-sectional study conducted in December 2024 with the consent of 200 undergraduate medical students of a tertiary care hospital affiliated medical college, who qualified as per the inclusion criteria.\n\nInclusion criteria:\n\nAll the students of MBBS Phase-II.\n\nExclusion criteria:\n\nStudents with prior diagnosed Sleep disorders Students with prior diagnosed co-morbidities Students unable/unwilling to answer the question.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Students of MBBS', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- All the students of MBBS Phase-II.\n\nExclusion criteria:\n\n* Students with prior diagnosed Sleep disorders\n* Students with prior diagnosed co-morbidities\n* Students unable/unwilling to answer the question.'}, 'identificationModule': {'nctId': 'NCT06953102', 'briefTitle': 'Prevalence and Association of Anxiety and Sleep Disturbances Among Medical Students.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Government Medical College, Patiala'}, 'officialTitle': 'The Prevalence and Association of Anxiety and Sleep Disturbances Among Medical Students: A Cross-sectional Study', 'orgStudyIdInfo': {'id': 'Trg.9(310)2024/13198-201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase-2 MBBS Students', 'description': 'The group included in Phase-2 MBBS Students i.e. 2nd year students in med school', 'interventionNames': ['Other: Survey using a questionnaire.']}], 'interventions': [{'name': 'Survey using a questionnaire.', 'type': 'OTHER', 'description': 'Survey was conducted to collect their responses to PSQI and BAI questionnaires.', 'armGroupLabels': ['Phase-2 MBBS Students']}]}, 'contactsLocationsModule': {'locations': [{'zip': '147001', 'city': 'Patiāla', 'state': 'Punjab', 'country': 'India', 'facility': 'Yuvraj Kaushal', 'geoPoint': {'lat': 30.33625, 'lon': 76.3922}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participant Confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Medical College, Patiala', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Yuvraj Kaushal', 'investigatorFullName': 'Yuvraj Kaushal', 'investigatorAffiliation': 'Government Medical College, Patiala'}}}}