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PainMUSIQNCT04671745

MUSIQ: MusicStudyImpactQualitative

An observational study of Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Dressing repairs cause distress and pain in children. Although drug analgesia is commonly used, some young children experience pain, distress and agitation. In these cases, the practice of care is not in line with a child-centred approach (CCC). Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Pain
What is being tested?
Music and No music
How many people
30 participants
Where
1 siteFrance
Study dates
Dec 2020to Dec 2021
How long will I take part?
1 Week
Phase
Observational
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 Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: All children (1 to 16 years old) who must have a bandage made with interactive music and who do not meet the criteria for non-inclusion. The parents of the children concerned by the observations, present during the care, having a good command of the French language. Professionals involved in care Musicians participating in the interactive music program

Who may be able to join

  • All children (from 0 to 16 years old) accompanied by their parent who need to have their bandage repaired

Who cannot join

  • Patient known to have severe hearing impairment warranting the use of hearing aids
  • Patient with a life-threatening emergency
  • End-of-life patient
  • Patient not benefiting from social security
  • Patient benefiting from State Medical Aid
  • Child whose parents are opposed to participation in research
Show all 9Show fewer
  • Parent who does not understand the French language
  • Protected adult parents
  • Parent or child who refuses the musician's presence

Trial locations and contacts

1 site in 1 country.

Bénédicte LOMBART contact

+33 1 71970854

benedicte.lombart@aphp.fr

France1 site
  • Hôpital Saint Antoine Coordination générale des soins

    Paris, 75571

Other trials in France

About this study

Official title: Qualitative Study of the Effect of Interactive Music on the " Child Centered Care Theory " During Dressing Changes in Children.

Dressing repairs cause distress and pain in children. Although drug analgesia is commonly used, some young children experience pain, distress and agitation.

In these cases, the practice of care is not in line with a child-centred approach (CCC). In addition, the use of non-pharmacological methods is recommended to optimize a child procedural pain management . In addition, the use of non-pharmacological methods is recommended to optimize a child procedural pain management in pediatrics. For this reason, interactive music can be proposed during the course of care. We suggest that interactive music transforms behaviour, attitudes, beliefs and convictions of the child, parents and caregivers during the dressing process, thereby altering the perception of pain and the overall experience of care.

The aim of this qualitative study is to explore what happens when children receive dressings in the presence of a musician trained in interactive music distribution in a hospital. Qualitative data will be generated through observation of clinical procedures by non-participant observers (n25) and semi-structured interviews with the musician, healthcare professionals, parents and children to explore this phenomenon from the participants' perspective. The data will be analysed by constant comparison. We will examine the actions, inactions and interactions of healthcare professionals, parents and children during dressing changes through the central theoretical concept of 'Child Centered Care'.

Read the detailed description

Pain and distress in children as a result of care procedures is documented (1) (2). Acute pain may have consequences in the short and long term(6) (7) (8,9). According to a Canadian study(10) the prevalence of procedural pain is 78% in the first 24 hours of hospitalization, dressing changes are common and are part of procedures that generate pain, including severe pain.

The influence of distress and anxiety is demontred in the modulation of pain perception (18,19). Therefore, the prevention of procedural pain must be multimodal (20). The value of non-pharmacological means to reduce pain and reduce the distress of the child during procedures is documented. (21-26). These approaches also help to limit the use of restraint during procedure. This practice is strating to be explored in the professional literature (27-32). The hypothesis of "transient empathic blindness" in the use of strong restraint during care " (37) could help to understand what happens in these circumstances. This phenomenon is to be linked to either a child-centred approach or one that focuses on the performance of the procedure. The Child Centered Care Theory suggests that child-centered care should be produced by focusing on the child himself or herself (38,39). These approaches are based on a combination of attitudes and behaviours that adjust to the child's reactions, welcome his emotions, respect his pacing, and allow him to make choices. This observation opens up new perspectives in the way in which the role of non-pharmacological methods is considered, particularly those involving more specifically human interactions. For they allow a practical and effective mediation of the relationship with the child.

According to a review of the literature concerning the effectiveness of integrative approaches to pain and anxiety in children and adolescents with cancer (46), music is one of the main strategies used by paediatric professionals to reduce pain and anxiety in children with distraction, virtual reality, hypno-analgesia, and massage, although the lack of randomized clinical trials concerning the use of these methods is to be deplored.

Randomized clinical trials on the value of music for procedural (23,53,54) or postoperative (55-57) pain have been conducted. There are several modalities for using music in the health field. These may be listening to recorded music (55,58,59) or to a specific programme to be listened to, or listening to so-called interactive music, i.e. a live musical session with the child by a musician (60,61). Interactive (or active) music, i.e., provided by a qualified musician trained in hospital intervention, using voice, body language and facial expression, can involve the child in a way that recorded music cannot (62). A meta-analysis of 30 early studies of the use of music in medical and dental procedures supports this assertion (63). One study compared the effects of live singing and guitar playing on adult patients hospitalized for cancer with the effects of recorded music of the same type. Active music allows for personalized musical expression that can be improvised in the context of care. This can be particularly crucial for young children to feel more comfortable. Indeed, musical support provided by song and an instrument may be best adapted to the child's immediate experience, as well as that of the parents and healthcare professionals providing the treatment. Indeed, we can imagine that music can help to introduce good interaction, which helps to regulate professional relations and relations with the patient and other professionals.

Live music was found to be more effective than recorded music in reducing anxiety and discomfort. (65) It is also known that parental stress can be significant when their child is ill and during medical procedures(68,69). Listening to music can reduce parental stress and improve parent-child interactions(48,70).

(48,70) Based on this finding, interactive music can transform the behaviours, attitudes, beliefs and convictions of the child, parents and caregivers.

Based on this observation, we could imagine that interactive music transforms the behaviours, attitudes, beliefs and convictions of the child, parents and caregivers when performing dressings, thus changing the child's approach and thus his behaviour and perception of treatment and pain. It is proposed that a child-centred approach improves care. The research hypothesis is therefore about the possibility that interactive music may promote a child-centred approach.

To date, no qualitative study has investigated the use of interactive music from the perspective of the participants in the theoretical perspective of the child-centred approach.

Qualitative research could explore what happens when children receive dressings on an outpatient basis in the presence of a musician trained in interactive music distribution at a teaching hospital by generating qualitative data through non-participatory observations of clinical procedures and semi-structured interviews with participants (musicians, health professionals, parents and children).

The aim is to question the triangulation of interactions from a philosophical and political perspective. The originality of this research is to seek to highlight the impact of interactive music on the philosophy of care through the central theoretical concept of "Child Centered Care". More globally, the vocation of this qualitative study is to widen the questioning to the political dimension by questioning the intervention of interactive music (human intervention) as a mediator of the social link. This exploratory qualitative study guided by the principles of grounded theory (71,72) will examine the actions, inactions and interactions that occur throughout the course of dressing changes, with an emphasis on the child's place in the interactions.

Conditions
Pain
Being tested
Music, No music
Keywords
Music, pain, Dressing, Childcentred care, Interaction
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MusicBehavioural

    patient receiving care with interactive music

  • No musicBehavioural

    patient receiving care without interactive music

Study groups in NCT04671745
Study groupRoleWhat they receive
Expérimentalpatient receiving care with interactive music
Receives: Behavioral: Music
Controlpatient receiving care without interactive music
Receives: Behavioral: No music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. observation grid developed on the basis of the main theoretical axes of CCC (Child Centred Care)

    Observe and record the interactions and behaviours of the child and caregivers during the procedure.

    Measured: the day of inclusion, up to one week after inclusion

Secondary outcomes (4)
  1. describe and conceptualize the processes involved when health professionals care for and interact with the child in the presence of active music and explain these processes.

    collect the words of parents and children to understand their point of view regarding the procedure performed with music

    Measured: the day of inclusion

  2. The FLACC (Face Legs Activity Cry Consolability) scale's score.

    The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

    Measured: the day of inclusion

  3. The PRIC (Procedural Restraint Intensity in Children) scale's score.

    The scale is scored in a range of 4 levels

    Measured: the day of inclusion

  4. The EVAN (Evaluation of Anxiety) scales's score

    The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

    Measured: the day of inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT04671745
Sponsor's protocol ID
APHP201159
Acronym
MUSIQ
Status last verified
Dec 2020
First submitted
19 Nov 2020
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bénédicte LOMBART (+33 1 71970854, benedicte.lombart@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

observation grid developed on the basis of the main theoretical axes of CCC (Child Centred Care) (time frame: the day of inclusion, up to one week after inclusion). 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 17 Dec 2020.

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MUSIQ: MusicStudyImpactQualitative (NCT04671745) | AzTrials