Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

iMpact of therapeUtic Live muSic on Pain and Distress Levels During Interventions in the paediatriC Emergency Department (Music:ED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956667
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Alder Hey Children's NHS Foundation Trust

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. 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. 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. 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.

Condition or disease Intervention/treatment Phase
Pain Other: Live Music Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

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.

Primary Purpose: Supportive Care
Official Title: Music:ED iMpact of therapeUtic Live muSic on Pain and Distress Levels During Interventions Within the paediatriC Emergency Department
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Live Music
Live Music will be played during the required Emergency Department procedure.
Other: Live Music
Musicians from Cascade Music will provide recruited participants in the experimental arm with high-quality calming, distracting music during their Emergency Department procedure.

No Intervention: Control: No Live Music
There will be no music played during the required Emergency Department procedure.



Primary Outcome Measures :
  1. Lower Self-Reported Pain scores in the Interventional Arm. [ Time Frame: One day ]
    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.

  2. Lower Observed Pain scores in the Interventional Arm. [ Time Frame: One day ]

    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.



Secondary Outcome Measures :
  1. Lower distress levels recorded in qualitative data collection in the interventional arm. [ Time Frame: One day ]
    Qualitative questions will be asked via a paper questionnaire regarding distress levels and experiences of patients, families and clinicians

  2. Reduced heart rates in the interventional compared to the control arm. [ Time Frame: One day ]
    Heart rate will be monitored throughout as an additional marker, where a child is cooperative enough. HR will be noted approximately every two minutes before, during and after procedure, (cleaning marks the beginning of the procedure, final bandage/dressing marks the completion). The Research Nurse will note HR data on the CRF. There will be an option for the Research Nurse to record 'not available' for heart rate measurements either because child refuses or because of probe or monitor issues etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956667


Contacts
Layout table for location contacts
Contact: Charlotte Durand, MBChBMRCPCH 01512525083 charlotte.durand@alderhey.nhs.uk
Contact: Rachel L Fillhart, BMus PGDip 07967800185 rfillhart@hotmail.com

Locations
Layout table for location information
United Kingdom
Alder Hey Children's NHS Foundation Trust Recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Contact: Research Alder Hey    0151 252 5570    research@alderhey.nhs.uk   
Sponsors and Collaborators
Alder Hey Children's NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Charlotte Durand, MBChBMRCPCH Alder Hey Children's Hospital
  Study Documents (Full-Text)

Documents provided by Alder Hey Children's NHS Foundation Trust:
Study Protocol  [PDF] November 13, 2018


Layout table for additonal information
Responsible Party: Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03956667     History of Changes
Other Study ID Numbers: 225890
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alder Hey Children's NHS Foundation Trust:
Paediatric
distress
Paediatric Emergency Department
Music
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes