Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-28 @ 4:28 PM
Study NCT ID:
NCT06072235
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2023-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facemasks and Chronic Pain Patients With Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'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': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric pain score, objective measurement using validated Numeric Pain Rating scale', 'timeFrame': '12 weeks', 'description': 'Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain'}], 'secondaryOutcomes': [{'measure': 'Depression score, objective measurement using validated Patient Health Questionnaire (PHQ-9) scale', 'timeFrame': '12 weeks', 'description': 'Depression score, using the Patient Health Questionnaire (PHQ-9) scale of 0-27; low scores indicate less depression, high scores indicate worse depression'}, {'measure': 'Anxiety score, objective measurement using validated General Anxiety Disorder (GAD-7) scale', 'timeFrame': '12 weeks', 'description': 'Anxiety score, using the General Anxiety Disorder (GAD-7) scale of 0-21; low scores indicate less anxiety, high scores indicate worse anxiety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': "Facemasks may impede communication. Impaired communication may worsen healthcare outcomes. This study explores the problem of hearing impairment in chronic pain patients, and the impact of facemasks on healthcare outcomes in chronic pain patients.\n\nData collection includes patient's age, anxiety score, depression score, numeric pain score, and effects of facemasks on treatment outcomes. Pain is measured using numeric pain rating scale. Depression is measured using the Patient Health Questionnaire (PHQ-9) scale. Anxiety is measured using the General Anxiety Disorder (GAD-7) scale.", 'detailedDescription': "Facemasks may impede communication. Impaired communication may worsen healthcare outcomes. There is inadequate data on the prevalence of hearing impairment in chronic pain patients. There is inadequate information about the impact of facemasks on treatment outcomes in chronic pain patients with hearing impairment. This prospective study explores the problem of hearing impairment in chronic pain patients, and the impact of facemasks on healthcare outcomes in chronic pain patients.\n\nThis is a prospective cohort study of adult patients undergoing pain treatment at an interventional pain clinic in Canada. Data collection includes patient's age, anxiety score, depression score, analgesic usage, numeric pain score, and effects of facemasks on pain management outcomes. Pain is measured using numeric pain rating scale of 0-10, with change of 2-points being considered significant. Depression is measured using the Patient Health Questionnaire (PHQ-9) scale of 0-27, with change of 3-points being considered significant. Anxiety is measured using the General Anxiety Disorder (GAD-7) scale of 0-21, with change of 3-points being considered significant.\n\nData are analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \\<0.05 is considered significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort of consecutive adult patients who underwent pain management at a pain clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* chronic pain diagnosis\n* diagnosed hearing impairment\n* use of hearing aid\n\nExclusion Criteria:\n\n* complete deafness\n* cochlear implant\n* severe vision impairment\n* cognitive dysfunction'}, 'identificationModule': {'nctId': 'NCT06072235', 'briefTitle': 'Facemasks and Chronic Pain Patients With Hearing Loss', 'organization': {'class': 'OTHER', 'fullName': 'Salem Anaesthesia Pain Clinic'}, 'officialTitle': 'Facemasks and COVID-19 Pandemic in Chronic Pain Patients With Hearing Impairment', 'orgStudyIdInfo': {'id': 'Salem2018 HearLoss Pain Mask'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Verbal communication', 'type': 'BEHAVIORAL', 'description': 'Verbal communication; by talking and listening'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3S 7J1', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Salem Anaesthesia Pain Clinic', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}], 'overallOfficials': [{'name': 'Olumuyiwa Bamgbade, MD,FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Salem Anaesthesia Pain Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salem Anaesthesia Pain Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}