Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT05410756
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2022-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Dysphonia And Anxiety In Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055154', 'term': 'Dysphonia'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2022-06-04', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Anxiety Questionary Score', 'timeFrame': 'at the start of the study', 'description': 'Measuring The Anxiety level, It is scored between 0-63. The greater the score the greater the anxiety level of the subject.'}, {'measure': 'Visual Analogue Scale (VAS) Score', 'timeFrame': 'at the start of the study', 'description': 'Visual Analogue Scale is used to measure the pain level of the subjects. It is scored between 0 to 10. Greater score corresponds to greater pain sensation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'fibromyalgia', 'dysphonia'], 'conditions': ['Dysphonia', 'Fibromyalgia', 'Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'Our aim in conducting this study is to determine the relationship between voice disorders and anxiety in patients with fibromyalgia syndrome (FS).', 'detailedDescription': 'This case controlled study was performed at the Physical Medicine and Rehabilitation outpatient clinic between April 2022 and June 2022. 25 patients who were diagnosed with FS according to the 2010 American College of Rheumatology (ACR) criteria were included in the study. For the control group 25 healthy volunteers with no previous chronic disease history were included . The investigators planed to investigate the relationship between the anxiety level of the FS patients and dysphonia. Thus an acoustic voice analysis (fundamental frequency (F0), jitter, shimmer, noise to harmonic ratio (NHR), harmonic to noise ratio (HNR)) and an aerodynamic analysis (maximal phonation time (MPT)) were performed by an experienced otolaryngologist specialized in voice disorders for evaluation of objective voice quality and function. These analyses were performed on all the volunteers from both groups, and the results obtained were compared between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25 patients diagnosed with fibromyalgia syndrome', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Fibromyalgia syndrome for at least 1 year\n* Minimum VAS score of 3\n\nExclusion Criteria:\n\n* Patients with diabetes mellitus,\n* other rheumatological diseases,\n* malignancies,\n* connective tissue disorders\n* neuromuscular diseases and\n* hereditary diseases.'}, 'identificationModule': {'nctId': 'NCT05410756', 'briefTitle': 'Relationship Between Dysphonia And Anxiety In Fibromyalgia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'Relationship Between Dysphonia And Anxiety In Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': 'B.10.1.THK.4.34.H.GP.0.01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FIBROMYALGIA GROUP', 'description': 'Patients diagnosed with Fibromyalgia Syndrome (n=25) who volunteered to be undergone voice analysis.', 'interventionNames': ['Diagnostic Test: Assessment of Voice Quality and Function']}, {'label': 'HEALTHY CONTROL GROUP', 'description': 'Healthy volunteers (n=25) without any chronic disease not under any medication volunteered to be undergone voice analysis.', 'interventionNames': ['Diagnostic Test: Assessment of Voice Quality and Function']}], 'interventions': [{'name': 'Assessment of Voice Quality and Function', 'type': 'DIAGNOSTIC_TEST', 'description': 'An acoustic voice analysis (fundamental frequency (F0), jitter, shimmer, noise to harmonic ratio (NHR), harmonic to noise ratio (HNR)) and an aerodynamic analysis (maximal phonation time (MPT)) were performed by an experienced otolaryngologist specialized in voice disorders for evaluation of objective voice quality and function. These analyses were performed on all the volunteers from both groups, and the results obtained were compared between the groups.', 'armGroupLabels': ['FIBROMYALGIA GROUP', 'HEALTHY CONTROL GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Umraniye Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Özlem Aslan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umraniye Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Özlem Kaleoğlu Aslan', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}