Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 1:50 AM
Study NCT ID:
NCT06165757
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mechanical pain sensitivity', 'timeFrame': 'from the study beginning to 30 min after the procedure', 'description': 'Each participant was measured using the pressure pain threshold and tolerance (tested by a pressure meter), which lower value present higher pain sensitivity'}, {'measure': 'cold pain sensitivity', 'timeFrame': 'from the study beginning to 30 min after the procedure', 'description': 'Each participant was measured using the cold pain threshold and tolerance (tested by immersion the hand in 4℃ water), which lower value present higher pain sensitivity'}, {'measure': 'electrical pain sensitivity', 'timeFrame': 'from the study beginning to 30 min after the procedure', 'description': 'Each participant was measured using the cold pain threshold and tolerance (tested by a electrical stimulator), which lower value present higher pain sensitivity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Noise', 'Pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Study the effects of 60dB and 80dB white noise, 50-70dB and 70-90dB non harmonic tones on the basic pain threshold of subjects, including the threshold and tolerance of electrical stimulation pain,the threshold and tolerance of cold pain stimulation, and the threshold and tolerance of tenderness stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 35, regardless of gender\n* No serious chronic diseases\n* There is no self-reported history of chronic opioid drug use or neuropathy\n\nExclusion Criteria:\n\n* A history of alcohol or drug abuse\n* Pregnant or lactating\n* Severe cardiovascular, kidney, or liver diseases'}, 'identificationModule': {'nctId': 'NCT06165757', 'briefTitle': 'The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers', 'orgStudyIdInfo': {'id': 'Noise and pain sensitivit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'noise on pain', 'description': 'Comparison of pain sensitivity before and after hearing noise among 15 subjects in each group.', 'interventionNames': ['Behavioral: noise stimulation']}], 'interventions': [{'name': 'noise stimulation', 'type': 'BEHAVIORAL', 'description': 'Apply non harmonic and white noise sound stimuli to the subjects, and then measure the threshold and tolerance values of pressure pain, cold pain, and electrical pain.', 'armGroupLabels': ['noise on pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'He Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital, Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}