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NCT03956667: Music:ED
iMpact of therapeUtic Live muSic on Pain and Distress Levels During Interventions in the paediatriC Emergency Department
NA trial testing Live Music in Pain in 109 participants. Completed in 18 September 2019.
18 September 2019
Quick facts
| Lead sponsor | Alder Hey Children's NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 109 |
| Start date | 29 January 2019 |
| Primary completion | 18 September 2019 |
| Estimated completion | 18 September 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Live Music
Conditions studied
- Pain — all drugs for Pain →
Sponsor
Alder Hey Children's NHS Foundation Trust
Who can join
Adults 6 Months to 16, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03956667
- Europe PMC full search
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Other Alder Hey Children's NHS Foundation Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03956667 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alder Hey Children's NHS Foundation Trust
- Last refreshed: 3 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03956667.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing