Music:ED iMpact of therapeUtic Live muSic on Pain and Distress Levels During Interventions Within the paediatriC Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Lower Self-Reported Pain scores in the Interventional Arm.
研究概览
简要总结
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.
详细描述
Value of the study:
There is a growing evidence-base for the use of music in healthcare settings, with music already demonstrated to reduce stress, distress and the perception of pain in some clinical contexts. Yet, there is a lack of studies examining the impact of live music in paediatric emergency contexts.
A literature review revealed that there is a lack of studies examining the impact of live music in paediatric emergency contexts.
Related studies either used recorded music in the place of live music, or, if live music was used, then it was within a non-emergency setting.
The Music:ED study will therefore use a controlled experimental design to investigate the impact of using therapeutic live music in the Alder Hey Paediatric Emergency Department to reduce pain and distress during interventional procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 6 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Lower Self-Reported Pain scores in the Interventional Arm.
时间窗: 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.
时间窗: 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.
次要结局
- 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)