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

Pain Clinical Trial

— MUCAFOCSS  

Official title:

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

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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
• 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
• 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 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.

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

Related Conditions & MeSH terms

• Anxiety
• Bandage
• Pain

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