Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT06277102
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-17', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-17', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture', 'timeFrame': 'postoperative day 1 and 2'}], 'secondaryOutcomes': [{'measure': 'Modified functional ambulatory classification (MFAC) in postoperative Day 3 among subjects with fragility hip fracture', 'timeFrame': 'postoperative day 3'}, {'measure': 'New mobility score (NMS) in postoperative Day 3 among subjects with fragility hip fracture', 'timeFrame': 'postoperative day 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain control', 'music', 'fragility hip fracture'], 'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.\n\nIn Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.\n\nThe aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Emergency admitted to QEH/G9 due to fragility hip fracture (#NOF or # TOF) within the study period\n2. Plan for surgical intervention\n3. Able to provide written informed consent\n4. Able to communicate in Cantonese/ Putonghua/ English\n\nExclusion Criteria:\n\n1. History of dementia\n2. Acute delirium upon admission\n3. Disorientated to time, person or place\n4. Concurrent fracture at other sites\n5. Utilization of other analgesics on top of pain protocol\n6. Appreciable deficits in hearing or vision\n7. Hemodynamically unstable\n8. Plan for neurolysis/ nerve block as definite treatment or opt for conservative treatment'}, 'identificationModule': {'nctId': 'NCT06277102', 'briefTitle': 'Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Authority, Hong Kong'}, 'officialTitle': 'Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Music pain FHF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music', 'description': 'Music listening at postoperative day 1 and 2, 1 session per day, 20 minutes per session.', 'interventionNames': ['Other: music listening']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care'}], 'interventions': [{'name': 'music listening', 'type': 'OTHER', 'description': 'Music listening at postoperative day 1 and 2, 1 session per day, 20 minutes per session.', 'armGroupLabels': ['Music']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kwan Yiu Jeffrey Lau', 'role': 'CONTACT', 'email': 'lky194a@ha.org.hk', 'phone': '62017014'}, {'name': 'Kwan Yiu Jeffrey Lau', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ward G9, Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Kwan Yiu Jeffrey Lau', 'role': 'CONTACT', 'email': 'lky194a@ha.org.hk', 'phone': '62017014'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Advanced Practice Nurse', 'investigatorFullName': 'Lau Kwan Yiu Jeffrey', 'investigatorAffiliation': 'Hospital Authority, Hong Kong'}}}}