BandageMUCAFOCSSNCT04038593
Impacts of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization (MUCAFOCSS)
A study testing Youtube© relaxation music and MUSIC CARE© intervention in people with Bandage and Pain, run by Fondation Oeuvre de la Croix Saint-Simon at 1 site in France.
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". Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Youtube© relaxation music and MUSIC CARE© intervention
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- reason for referral "complex dressing"
- age > 18 year old
- inform consent
- pain numerical scale ≥3 during care
- able to speak and write French
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Oeuvre de la Croix Saint-Simon
Paris, Île-de-France Region, 75019
About this study
Official title: 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.
Read the 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.
- Being tested
- Youtube© relaxation music, MUSIC CARE© intervention
- Keywords
- Pain, Anxiety, Complex dressing, Home hospitalization, Music
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youtube© relaxation musicOther
Also called Youtube© condition
Use of non standardized relaxation music with Youtube© during cares
MUSIC CARE© interventionDevice
Also called MUSIC CARE© condition
Use of MUSIC CARE© during cares
| Study group | Role | What they receive |
|---|---|---|
| Non interventional arm | No intervention | Standard conditions of complex dressing cares, without experimental intervention. It will be a control intervention |
| Comparative arm with relaxation music from Youtube© | Active comparator | Standard conditions of complex dressing cares + use of non standardized music relaxation during complex dressing cares Receives: Other: Youtube© relaxation music |
| Interventional arm with MUSIC CARE© | Experimental | 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. Receives: Device: MUSIC CARE© intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain felt during the care: numerical scale
Measurement by a numerical scale (0 the minimum to 10 the maximum)
Measured: Immediately after the intervention
Secondary outcomes (4)
Anxiety measurement
Measurement assessed by numerical scale (0 the minimum to 10 the maximum)
Measured: Immediately before/after the intervention
Time needed for the care
Measurement by caregivers
Measured: Immediately before/after the intervention
Satisfaction of patient and caregivers: numerical scale
Measurement by numerical scale (0 the minimum to 10 the maximum)
Measured: Immediately after the intervention
Treatment request by the patient during the care
Measurement by a dichotomous question (Yes/No)
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study startJan 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BandageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Oeuvre de la Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémy Martin, Principal investigator, Fondation Oeuvre de la Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038593
- Sponsor's protocol ID
- FOCSS-2019-1
- Other IDs
- 2019-A01320-57
- Acronym
- MUCAFOCSS
- Status last verified
- Mar 2022
- First submitted
- 13 Jul 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of a Standardized Musical Intervention on Complex Dressing Care During Home Hospitalization: a Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT04038593
- Acronym / sponsor ID
- MUCAFOCSS / FOCSS-2019-1
- Keywords
- Pain, Anxiety, Complex dressing, Home hospitalization, Music
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Oeuvre de la Croix Saint-SimonUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non interventional arm | No intervention | –Standard conditions of complex dressing cares, without experimental intervention. It will be a control intervention |
| Comparative arm with relaxation music from Youtube© | Active comparator | Other: Youtube© relaxation musicStandard conditions of complex dressing cares + use of non standardized music relaxation during complex dressing cares |
| Interventional arm with MUSIC CARE© | Experimental | Device: MUSIC CARE© interventionStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- reason for referral "complex dressing"
- age > 18 year old
- inform consent
- pain numerical scale ≥3 during care
- able to speak and write French
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youtube© relaxation musicAlso: Youtube© conditionUse of non standardized relaxation music with Youtube© during cares | Other | Comparative arm with relaxation music from Youtube© |
| MUSIC CARE© interventionAlso: MUSIC CARE© conditionUse of MUSIC CARE© during cares | Device | Interventional arm with MUSIC CARE© |
Primary outcome
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)
4 secondary outcomes
Anxiety measurement
Time frame: Immediately before/after the intervention
Time needed for the care
Time frame: Immediately before/after the intervention
Satisfaction of patient and caregivers: numerical scale
Time frame: Immediately after the intervention
Treatment request by the patient during the care
Time frame: Immediately after the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérémy Martin principal investigator
Fondation Oeuvre de la Croix Saint-Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youtube© relaxation music and MUSIC CARE© intervention in people with Bandage and Pain, run by Fondation Oeuvre de la Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain felt during the care: numerical scale (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.