Impacts of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization (MUCAFOCSS)

Study Overview
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Brief Summary
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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. The 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.

Detailed Description
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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. Complex 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. MUSIC 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. The 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. Participants 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.

Official Title
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Feasibility and Effects of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization: a Controlled and Randomized Study

Conditions
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Bandage, Pain, Anxiety

Intervention / Treatment
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* Other: Youtube© relaxation music
* Device: MUSIC CARE© intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: reason for referral complex dressing age > 18 year old inform consent pain numerical scale ≥3 during care able to speak and write French Exclusion Criteria: patients with a deficiency in auditive function patients diagnosed with psychiatric pathologies so-called vulnerable patients, ie under guardianship or curatorship, or deprived of their liberty by a judicial or administrative decision

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non interventional arm<br>Standard conditions of complex dressing cares, without experimental intervention. It will be a control intervention | |
| Active Comparator: Comparative arm with relaxation music from Youtube©<br>Standard conditions of complex dressing cares + use of non standardized music relaxation during complex dressing cares | Other: Youtube© relaxation music<br>* Use of non standardized relaxation music with Youtube© during cares<br>* Other names: Youtube© condition;|
| Experimental: Interventional arm with MUSIC CARE©<br>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. | Device: MUSIC CARE© intervention<br>* Use of MUSIC CARE© during cares<br>* Other names: MUSIC CARE© condition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain felt during the care: numerical scale | Measurement by a numerical scale (0 the minimum to 10 the maximum) | Immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety measurement | Measurement assessed by numerical scale (0 the minimum to 10 the maximum) | Immediately before/after the intervention | 
| Time needed for the care | Measurement by caregivers | Immediately before/after the intervention | 
| Satisfaction of patient and caregivers: numerical scale | Measurement by numerical scale (0 the minimum to 10 the maximum) | Immediately after the intervention | 
| Treatment request by the patient during the care | Measurement by a dichotomous question (Yes/No) | Immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Anxiety, Complex dressing, Home hospitalization, Music