MUSIQ: MusicStudyImpactQualitative

NCT04671745 | Unknown

• 1 other identifier: APHP201159
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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'.

Conditions

Pain

Keywords

Music; pain; Dressing; Childcentred care; Interaction

Outcome Measures

Primary Outcomes (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.

  the day of inclusion, up to one week after inclusion

Secondary Outcomes (4)

• 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.

  the day of inclusion

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

  the day of inclusion

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

  the day of inclusion

• The EVAN (Evaluation of Anxiety) scales's score

  the day of inclusion

Study Arms (2)

Expérimental

patient receiving care with interactive music

Behavioral: Music

Control

patient receiving care without interactive music

Behavioral: No music

Interventions

Music BEHAVIORAL

patient receiving care with interactive music

Expérimental

No music BEHAVIORAL

patient receiving care without interactive music

Control

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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

You may qualify if:

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

You may not qualify if:

• 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
• Parent who does not understand the French language
• Protected adult parents
• Parent or child who refuses the musician's presence

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Antoine Coordination générale des soins

Paris, 75571, France

Location

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bénédicte LOMBART

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bénédicte LOMBART

CONTACT

+33 1 71970854; benedicte.lombart@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 17, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)