Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-01 @ 3:15 PM
Study NCT ID:
NCT05002257
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety postoperative in a postanesthesic care unit (PACU) after spinal anesthesia', 'timeFrame': 'Day 0', 'description': "Anxiety is assess by using Spielberg's STAI-Ya from 20 (no anxiety) to 80 (anxiety)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PACU', 'pain', 'care', 'music', 'anxiety'], 'conditions': ['Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research.', 'detailedDescription': 'We want to demonstrate that listening to music:\n\n* decreases the anxiety of patients in PHC;\n* improves their overall satisfaction unlike patients subjected to ambient noise from the SSPI. Demonstrate that there is a link between trait anxiety assessed preoperatively and state anxiety assessed immediate postoperative period to anticipate and improve patient care as soon as they arrive in SSPI. Extend music listening to all patients staying in a postoperative SSPI or for procedures performed in SSPI (bladder probing, central venous approach, post locoregional analgesia operative…) The Music Care software that we have chosen to use has been specifically developed to use the music as a therapeutic aid. Numerous abstracts and clinical studies have been published on the subject the use of this software in reducing anxiety, pain, behavioral and changes in hemodynamic parameters. It is based on the use of the so-called "U" method, which is a relaxation method based on hypno-analgesia, thus offering a complete relaxation session to patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria :\n\n* adult patients;\n* undergoing scheduled orthopedic surgery, under spinal anesthesia;\n* non-cancerous, functional;\n* in traditional or outpatient hospitalization;\n* requiring a passage in PACU;\n* agreeing to participate in the study (consent form).\n\nexclusion criteria :\n\n* Children;\n* under tutorship or curatorship;\n* having known hearing problems (hearing loss or not, deafness) reported during the anesthesia consultation or detected during the collection of preoperative data; having cognitive disorders (dementia, disorientation) reported during the consultation of anesthesia, not allowing questions to be answered\n* Patients equipped with their personal music.\n\nThe following will be excluded when they arrive in SSPI:\n\n* Patients who received a benzodiazepine during the intraoperative period;\n* Patients whose spinal anesthesia has been converted to general anesthesia;'}, 'identificationModule': {'nctId': 'NCT05002257', 'acronym': 'MusicAnx-SSPI', 'briefTitle': 'Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'PP21063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'interventionNames': ['Other: music therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'interventionNames': ['Other: No music therapy']}], 'interventions': [{'name': 'music therapy', 'type': 'OTHER', 'description': "Patients included in the intervention arm with music therapy will choose among 3 possible music: music from elsewhere, classical music, today's music. These 3 music thearpy will have an identical duration of 20 minutes.", 'armGroupLabels': ['Experimental Arm']}, {'name': 'No music therapy', 'type': 'OTHER', 'description': 'Usual care', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'country': 'France', 'facility': 'Damien JOLLY', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}