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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain; Anxiety; Bandage
• Intervention / Treatment: Other: Youtube© relaxation music; Device: MUSIC CARE© intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75019
      • Fondation Oeuvre de la Croix Saint-Simon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: MUSIC CARE© condition

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondation Oeuvre de la Croix Saint-Simon
• Investigators: Principal Investigator: Jérémy Martin, Fondation Oeuvre de la Croix Saint-Simon

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 13, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Music; Complex dressing; Home hospitalization
• Other Study ID Numbers: FOCSS-2019-1; 2019-A01320-57 (Other Identifier: Agence Nationale de Sécurité du Médicament (ANSM) ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No