Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-31 @ 5:56 PM
Study NCT ID:
NCT04038593
Status:
WITHDRAWN
Last Update Posted:
2022-03-31
First Post:
2019-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impacts of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization (MUCAFOCSS)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'COVID', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2019-07-13', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain felt during the care: numerical scale', 'timeFrame': 'Immediately after the intervention', 'description': 'Measurement by a numerical scale (0 the minimum to 10 the maximum)'}], 'secondaryOutcomes': [{'measure': 'Anxiety measurement', 'timeFrame': 'Immediately before/after the intervention', 'description': 'Measurement assessed by numerical scale (0 the minimum to 10 the maximum)'}, {'measure': 'Time needed for the care', 'timeFrame': 'Immediately before/after the intervention', 'description': 'Measurement by caregivers'}, {'measure': 'Satisfaction of patient and caregivers: numerical scale', 'timeFrame': 'Immediately after the intervention', 'description': 'Measurement by numerical scale (0 the minimum to 10 the maximum)'}, {'measure': 'Treatment request by the patient during the care', 'timeFrame': 'Immediately after the intervention', 'description': 'Measurement by a dichotomous question (Yes/No)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Anxiety', 'Complex dressing', 'Home hospitalization', 'Music'], 'conditions': ['Bandage', 'Pain', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'In France, home hospitalization services (HAD) are developing as an alternative to conventional hospitalization. In order to intervene at patients\' home, a reason for referral must be defined. The most common one on the national territory is "complex dressing". Cares associated with these dressings can lead to symptoms such as pain and/or anxiety, and thus decrease the patient\'s quality of life. These two symptoms may be related, with the presence of one increasing the intensity of the other. Thus, drug treatments are often implemented as part of care, but may not be sufficient to relieve patients. Music has many interests in patients\' pain and anxiety. MUSIC CARE© application allows the implementation of standardized musical interventions. It has been shown to be effective in reducing acute and chronic pain and anxiety in many clinical settings.\n\nThe aim of this study is to evaluate the feasibility of implementing MUSIC CARE© in the care of complex dressings at home and to confirm its effectiveness on the symptoms experienced by patients. In addition, attention will be paid to the impact of this standardized musical intervention on care time, medication use during care and patients\' and caregivers\' satisfaction.', 'detailedDescription': "Complex dressing reason for referral represent one of the most frequent case in home hospitalization (HAD) referrals, accounting for 28.4% of HAD days in 2018 at national level. They can occur for different pathologies. They involve daily or several times a week care to repair dressings, monitor wound progress and healing.\n\nComplex dressings care can lead to symptoms for the patient such as pain and/or anxiety. Those symptoms can be related. In fact, anxiety could influence the patient's feelings and assessment of pain.\n\nMUSIC CARE© allows the implementation of standardized musical interventions. This technique can be compared to sophrology and hypnosis, but verbal suggestions are replaced by musical suggestions. This application is considered effective in reducing acute and chronic pain, reducing anxiety, reducing drug use in different clinical settings, and developing good patient satisfaction by international literature.\n\nThe hypothesis of this study is that the use of MUSIC CARE© during complex dressing home care could reduce patients' pain and anxiety, reduce patients' requests for drug treatments, reduce the time required for care, and develop a positive level of satisfaction among patients and caregivers.\n\nParticipants will be recruited during their hospitalization at the HAD of Fondation Oeuvre de la Croix Saint-Simon (Ile de France). A randomization list will be created upfront to determine the order of passage under the experimental conditions. After verification of the inclusion criteria and study proposal, patients who agree to participate will sign a free and informed consent form and will be assigned a coded identification number. They will respond to two measurement times, one before and one after the care. Caregivers will also complete questionnaires In order to obtain statistically exploitable results, 250 patients will be included."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* reason for referral "complex dressing"\n* age \\> 18 year old\n* inform consent\n* pain numerical scale ≥3 during care\n* able to speak and write French\n\nExclusion Criteria:\n\n* patients with a deficiency in auditive function\n* patients diagnosed with psychiatric pathologies\n* so-called vulnerable patients, ie under guardianship or curatorship, or deprived of their liberty by a judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT04038593', 'acronym': 'MUCAFOCSS', 'briefTitle': 'Impacts of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization (MUCAFOCSS)', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Oeuvre de la Croix Saint-Simon'}, 'officialTitle': 'Feasibility and Effects of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization: a Controlled and Randomized Study', 'orgStudyIdInfo': {'id': 'FOCSS-2019-1'}, 'secondaryIdInfos': [{'id': '2019-A01320-57', 'type': 'OTHER', 'domain': 'Agence Nationale de Sécurité du Médicament (ANSM) ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Non interventional arm', 'description': 'Standard conditions of complex dressing cares, without experimental intervention. It will be a control intervention'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparative arm with relaxation music from Youtube©', 'description': 'Standard conditions of complex dressing cares + use of non standardized music relaxation during complex dressing cares', 'interventionNames': ['Other: Youtube© relaxation music']}, {'type': 'EXPERIMENTAL', 'label': 'Interventional arm with MUSIC CARE©', 'description': 'Standard conditions of complex dressing cares + administration of a specific music therapy program (U method) delivered through headphones from a tablet, under the direction of trained nurses.', 'interventionNames': ['Device: MUSIC CARE© intervention']}], 'interventions': [{'name': 'Youtube© relaxation music', 'type': 'OTHER', 'otherNames': ['Youtube© condition'], 'description': 'Use of non standardized relaxation music with Youtube© during cares', 'armGroupLabels': ['Comparative arm with relaxation music from Youtube©']}, {'name': 'MUSIC CARE© intervention', 'type': 'DEVICE', 'otherNames': ['MUSIC CARE© condition'], 'description': 'Use of MUSIC CARE© during cares', 'armGroupLabels': ['Interventional arm with MUSIC CARE©']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Fondation Oeuvre de la Croix Saint-Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jérémy Martin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Oeuvre de la Croix Saint-Simon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Oeuvre de la Croix Saint-Simon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}