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

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ClinicalTrials.gov Identifier: NCT04038593
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Oeuvre de la Croix Saint-Simon

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bandage Pain Anxiety Other: Youtube© relaxation music Device: MUSIC CARE© intervention Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Effects of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization: a Controlled and Randomized Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Non interventional arm
Standard conditions of complex dressing cares, without experimental intervention. It will be a control intervention
Active Comparator: Comparative arm with relaxation music from Youtube©
Standard conditions of complex dressing cares + use of non standardized music relaxation during complex dressing cares
Other: Youtube© relaxation music
Use of non standardized relaxation music with Youtube© during cares
Other Name: Youtube© condition

Experimental: Interventional arm with MUSIC CARE©
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
Use of MUSIC CARE© during cares
Other Name: MUSIC CARE© condition




Primary Outcome Measures :
  1. Pain felt during the care: numerical scale [ Time Frame: Immediately after the intervention ]
    Measurement by a numerical scale (0 the minimum to 10 the maximum)


Secondary Outcome Measures :
  1. Anxiety measurement [ Time Frame: Immediately before/after the intervention ]
    Measurement assessed by numerical scale (0 the minimum to 10 the maximum)

  2. Time needed for the care [ Time Frame: Immediately before/after the intervention ]
    Measurement by caregivers

  3. Satisfaction of patient and caregivers: numerical scale [ Time Frame: Immediately after the intervention ]
    Measurement by numerical scale (0 the minimum to 10 the maximum)

  4. Treatment request by the patient during the care [ Time Frame: Immediately after the intervention ]
    Measurement by a dichotomous question (Yes/No)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038593


Contacts
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Contact: Jérémy Martin +33 698587427 j.martin@lafocss.org
Contact: Camille Baussant-Crenn +33 662398832 c.baussant-crenn@lafocss.org

Locations
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France
Fondation Oeuvre de la Croix Saint-Simon
Paris, Ile De France, France, 75019
Contact: Jérémy Martin    +33 698587427    j.martin@lafocss.org   
Contact: Camille Baussant-Crenn    +33 662398832    c.baussant-crenn@lafocss.org   
Sponsors and Collaborators
Fondation Oeuvre de la Croix Saint-Simon
Investigators
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Principal Investigator: Jérémy Martin Fondation Oeuvre de la Croix Saint-Simon
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Responsible Party: Fondation Oeuvre de la Croix Saint-Simon
ClinicalTrials.gov Identifier: NCT04038593    
Other Study ID Numbers: FOCSS-2019-1
2019-A01320-57 ( Other Identifier: Agence Nationale de Sécurité du Médicament (ANSM) ID-RCB )
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Oeuvre de la Croix Saint-Simon:
Pain
Anxiety
Complex dressing
Home hospitalization
Music