iMpact of therapeUtic Live muSic on Pain and Distress Levels During Interventions in the paediatriC Emergency Department

NCT03956667 | Completed

• 1 other identifier: 225890
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The Emergency Department (ED) can be stressful and traumatic, especially for children and young people, and the clinical environment can be a frightening, unfamiliar space, which adds to an already anxious experience. Musicians from Cascade Music, who have an established track record of working with the Paediatric ED, will provide recruited participants in the experimental arm with high-quality calming, distracting music during selected procedures. A wide range of music will be used, ranging from nursery rhymes to classical to pop tunes, to engage with and comfort children, taking their attention away from their immediate pain or distress. Pain scores throughout the procedure will be self-assessed by patients (if old enough to use a self assessment tool i.e. 3 years and above) as well as observed by a Research Nurse. Qualitative data on distress and the experiences of patients, families and staff will also be collected via a questionnaire. Participants recruited to the control arm will complete the same measures but receive no live music. This project is underpinned by three areas of need:

1. 1.Despite there being a wide breadth of clinical studies that have used music within various healthcare settings, one area that has been almost completely unexplored is the Paediatric Emergency Department (PED). Alder Hey Children's Hospital (AHCH), as a world leader in research, is ideally situated to conduct this preliminary research.
2. 2.By 2020 AHCH plans to be a world class, child-focused centre of research, innovation and education expertise to improve the health and wellbeing outcomes for children and young people. Supporting patients through stressful and invasive procedures is crucial. Inspired by the patients and families that we care for, this research fits well with the AHCH vision, demonstrating an innovative and evidence-informed approach to enhancing practice.
3. 3.The University of Liverpool's impact intensive approach to research is a key strength. This study is designed to have a positive immediate impact on the children and young people participating and those undergoing interventional procedures in the future, helping to enhance patient experience of the ED.

Conditions

Pain

Keywords

Paediatric; distress; Paediatric Emergency Department; Music

Outcome Measures

Primary Outcomes (2)

• Lower Self-Reported Pain scores in the Interventional Arm.

  Participants' Self-Reported pain scores will be noted by the Research Nurse using the Wong-Baker pain scoring tool. Scores will be collected before, during and after the procedure.

  One day

• Lower Observed Pain scores in the Interventional Arm.

  Observed Pain scores will be observed and collected by the Research Nurse using the FLACC (Faces, Legs, Activity, Cry and Consolability) pain scoring tool. FLACC Scoring will take place before, during and after the procedure.

  One day

Secondary Outcomes (2)

• Lower distress levels recorded in qualitative data collection in the interventional arm.

  One day

• Reduced heart rates in the interventional compared to the control arm.

  One day

Study Arms (2)

Experimental: Live Music

EXPERIMENTAL

Live Music will be played during the required Emergency Department procedure.

Other: Live Music

Control: No Live Music

NO INTERVENTION

There will be no music played during the required Emergency Department procedure.

Interventions

Live Music OTHER

Musicians from Cascade Music will provide recruited participants in the experimental arm with high-quality calming, distracting music during their Emergency Department procedure.

Experimental: Live Music

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/Legal Guardian present and able to consent.
• Age range: 6 months - 16 years.
• Procedures: Capillary blood sampling, cannulation, venepuncture, suturing, wound cleaning and closure.
• Families and children whose primary language is other than English will be included in the study if their English speaking skills are at a level that they can understand and complete the consent/assent process.

You may not qualify if:

• Children with Special Educational Needs, children with global development delay, sensory impairments, neurological deficits or disorders, impairment to pain i.e. spina bifida.
• Children in resuscitation or unconscious.
• Non-English speaking.
• Suspected ingestion of recreational drugs, antidepressants or alcohol
• Concerns relating to NAI (non accidental injury)/safeguarding concerns
• Life or limb critical injuries
• Children too unwell to participate

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (1)

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Charlotte Durand, MBChBMRCPCH

  Alder Hey Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be recruited to the experimental (Live Music) arm on days that the musicians are working in the Emergency Department. Participants will be recruited to the control (Non Music) arm on days that there are no musicians present in the Emergency Department.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: May 21, 2019
• Study Start: January 29, 2019
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: August 3, 2021

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)