iMpact of therapeUtic Live muSic on Pain and Distress Levels During Interventions in the paediatriC Emergency Department (Music:ED)
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|ClinicalTrials.gov Identifier: NCT03956667|
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
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:
- 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.
- 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.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
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|
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.
- 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.
- 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.
- 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
- 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.
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
|Contact: Charlotte Durand, MBChBMRCPCHemail@example.com|
|Contact: Rachel L Fillhart, BMus PGDipfirstname.lastname@example.org|
|Alder Hey Children's NHS Foundation Trust||Recruiting|
|Liverpool, Merseyside, United Kingdom, L12 2AP|
|Contact: Research Alder Hey 0151 252 5570 email@example.com|
|Principal Investigator:||Charlotte Durand, MBChBMRCPCH||Alder Hey Children's Hospital|