Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04948320
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2021-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temporomandibular Dysfunction Affects Neck Disability, Headache, Anxiety, And Sleep Quality In Women: A Cross-Sectional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-27', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-06-27', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Fonseca Anamnestic Index', 'timeFrame': 'Baseline'}, {'measure': 'Numerical Rating Scale', 'timeFrame': 'Baseline'}, {'measure': 'Neck Disability Index', 'timeFrame': 'Baseline'}, {'measure': 'Headache Impact Test', 'timeFrame': 'baseline'}, {'measure': 'General Anxiety Disorder-7 Scale', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Disorders', 'Headache', 'Neck Disorder', 'Anxiety', 'Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'The temporomandibular joint (TMJ), is the only movable joint between the joints in the head and neck system. It is a component of the chewing system and is involved in important functions such as speech, swallowing, taste and breathing. Temporomandibular dysfunction (TMD) is the general name given to various musculoskeletal problems seen in the stomatognathic system, mostly affecting the masticatory muscles and/or TMJ. TMD is the second most common musculoskeletal pain after chronic low back pain. Patients with TMD may also complain of other musculoskeletal problems, craniocervical problems, sleep problems, and anxiety disorders. The aim of this study is to investigate, compare and examine the relationship between neck dysfunction, headache and temporomandibular dysfunction severity, anxiety and sleep quality in female individuals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'temporomandibular disorder and healthy women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 65 years\n* Temporomandibular disorders more than 6 months\n* Volunteering\n\nExclusion Criteria:\n\n* Cranio-cervical trauma and temporomandibular operation history\n* Infection\n* 20-40 points from Fonseca Anamnestic Index 20-40 points'}, 'identificationModule': {'nctId': 'NCT04948320', 'briefTitle': 'Temporomandibular Dysfunction Affects Neck Disability, Headache, Anxiety, And Sleep Quality In Women: A Cross-Sectional Study', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'Temporomandibular Dysfunction Affects Neck Disability, Headache, Anxiety, And Sleep Quality In Women: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': '2020-43'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Temporomandibular Disorder Group'}, {'label': 'Control Group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Yildirim Beyazit University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'sevilay seda bas', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}