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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04038593
Other study ID # FOCSS-2019-1
Secondary ID 2019-A01320-57
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2022
Est. completion date December 2022

Study information

Verified date March 2022
Source Fondation Oeuvre de la Croix Saint-Simon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 CAREĀ© 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 CAREĀ© 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Youtube© relaxation music
Use of non standardized relaxation music with Youtube© during cares
Device:
MUSIC CARE© intervention
Use of MUSIC CARE© during cares

Locations

Country Name City State
France Fondation Oeuvre de la Croix Saint-Simon Paris Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Fondation Oeuvre de la Croix Saint-Simon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain felt during the care: numerical scale Measurement by a numerical scale (0 the minimum to 10 the maximum) Immediately after the intervention
Secondary Anxiety measurement Measurement assessed by numerical scale (0 the minimum to 10 the maximum) Immediately before/after the intervention
Secondary Time needed for the care Measurement by caregivers Immediately before/after the intervention
Secondary Satisfaction of patient and caregivers: numerical scale Measurement by numerical scale (0 the minimum to 10 the maximum) Immediately after the intervention
Secondary Treatment request by the patient during the care Measurement by a dichotomous question (Yes/No) Immediately after the intervention
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