Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT04819750
Status:
UNKNOWN
Last Update Posted:
2021-03-29
First Post:
2021-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-assessed anxiety score between the 2 groups', 'timeFrame': 'Baseline day, when entering the operating room', 'description': 'Self-assessed anxiety score on a visual analogue scale (VAS) from 0 to 10 (0 means no anxiety and 10 the maximum anxiety)'}], 'secondaryOutcomes': [{'measure': 'Self-assessment of the duration of the surgery', 'timeFrame': 'Baseline day, when entering the operating room', 'description': 'Self-rated duration of surgery on a scale of 0 to 5 (0 means 5 to 10 minutes and 5 means 25 to 30 minutes)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Cataract surgery with topic anesthesia is anxiety provoking. This operative stress can increase pain perception and blood pressure. This discomfort can lead to non-compliance with immobility and potentially lead to intraoperative and postoperative complications.\n\nPharmacological means are limited to reduce anxiety. Only anxiolytics could be effective but at the cost of side effects not compatible with surgery.\n\nMusic Care is a "digital treatment" allowing the diffusion of music with a U-shaped sequence using the principles of hypnoanalgesia.\n\nThe objective of this study is to evaluate the effectiveness of the MusicCare listening device on the anxiety of patients during cataract surgery with topic anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cataract surgery with topical anesthesia\n\nExclusion Criteria:\n\n* Hearing impaired patient'}, 'identificationModule': {'nctId': 'NCT04819750', 'briefTitle': 'Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia', 'orgStudyIdInfo': {'id': 'MUSICOTOPICAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MusicCare® device', 'description': 'The device is a touch tablet with a headset that allows noise reduction. The patient can choose the music they prefer. The selected U-shaped sequence uses the principles of hypnoanalgesia to accompany the patient into a state of deep relaxation.', 'interventionNames': ['Device: MusicCare® device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Headphones with noise reduction', 'description': 'Headphones with noise reduction without music', 'interventionNames': ['Device: Headphones with noise reduction']}], 'interventions': [{'name': 'MusicCare® device', 'type': 'DEVICE', 'description': 'The device is a touch tablet with a headset that allows noise reduction. The patient can choose the music they prefer. The selected U-shaped sequence uses the principles of hypnoanalgesia to accompany the patient into a state of deep relaxation.', 'armGroupLabels': ['MusicCare® device']}, {'name': 'Headphones with noise reduction', 'type': 'DEVICE', 'description': 'Headphones with noise reduction without music', 'armGroupLabels': ['Headphones with noise reduction']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Benjamin Javillier, MD', 'role': 'CONTACT', 'email': 'javillier.benjamin@hotmail.com', 'phone': '042843820', 'phoneExt': '+32'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin Javillier', 'investigatorAffiliation': 'University of Liege'}}}}