Effect of a Personalized Music Intervention on Stress Reduction in the Paediatric Intensive Care Unit: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- The main study endpoint is patient comfort measured with the Dutch Version of the COMFORT Behavior (COMFORT-B) scale
研究概览
简要总结
Rationale: Admission into a pediatric intensive care unit (PICU) can be a highly stressful experience, with many children demonstrating posttraumatic stress symptoms. Most patients require titration of pain and sedation medications to facilitate care, but there is increasing concern of the impact of these medications on the developing brain and increased health risks, including drug withdrawal syndrome, delirium, and impaired circadian rhythm. One potential nonpharmacologic approach to decreasing stress and improving comfort is live-performed music therapy. Among mechanically ventilated adults, music therapy decreased physiologic and psychologic responses to stress (e.g., vital signs, self-reported anxiety) and sedative use. The use of live-performed music may be more advantageous than recorded music with a critically ill population because a music therapist is trained to manipulate musical elements to facilitate the desired outcomes and can respond immediately and adequately in response to the patient's reactions.
Objective: To study the effects of live-music therapy on patient comfort, and on patient and parental stress levels and parent-child interaction, use of sedato-analgesic drugs, on haemodynamics and respiration and on the occurrence of patient-ventilator synchrony.
Study design: Randomised, non-blinded pilot study Study population: Children < 5 years old and with expected mechanical ventilatory support for at least 48 hours after inclusion.
Intervention: Live-music or care-as-usual. Main study parameters/endpoints: The main study endpoint is patient comfort measured with the Dutch Version of the COMFORT Behaviour (COMFORT-B) scale. Secondary endpoints include parental stress levels, changes in hemodynamic variables (heart rate, blood pressure), changes in respiratory parameters (respiration rate, oxygen saturation, pressure-rate product, pressure-time product), daily cumulative dose of benzodiazepines, alpha-2-agonists and opioids, on-demand boluses of benzodiazepines and opioids, number of asynchronous breaths, and DNA methylation of stress genes,
详细描述
- Problem definition Admission into a pediatric intensive care unit (PICU) can be a highly stressful experience, with up to 62% of children demonstrating posttraumatic stress symptoms following a PICU admission. The PICU is for many critically ill children a toxic rather than a healing environment. Children needing invasive and/or painful procedures during their PICU stay are particularly at increased risk of these sequelae, with most requiring titration of pain and sedation medications to facilitate care. Caregiver and provider concern for the unclear impact of pain and sedative medications on the developing brain and increased health risks (e.g., physiologic instability, ICU acquired weakness, withdrawal and dependence, delirium, sleep-wake cycle disturbances due to patient-ventilator asynchrony, and long-term health outcomes) are energizing interest into trials investigating ancillary approaches to comfort. It is therefore crucial to explore and validate nonpharmacologic interventions toward child comfort in the PICU to alleviate some of these hazards.
One potential approach to decreasing stress and improving comfort is live-performed music therapy. Music and medicine have a long history of being entwined, going as far back as the Greek philosopher Pythagoras prescribing music to promote health. There is an increasing interest in studying music's impact on health outcomes. Among mechanically ventilated adults, music therapy decreased physiologic and psychologic responses to stress (e.g., vital signs, self-reported anxiety) and sedative use.
It is important to differentiate between "music therapy" and the general provision of music, sometimes referred to as "music medicine". Both music therapy and music medicine have been found to decrease pain, increase physical, cognitive, and speech recovery, and improve quality of life. Although music therapy is provided by a credentialed therapist who uses music-based interventions for individualized goal attainment, music medicine is typically prerecorded music provided by a medical. The use of live-performed music may be more advantageous than recorded music with a critically ill population because a music therapist is trained to manipulate musical elements to facilitate the desired outcomes and can respond immediately and adequately in response to the patient's reactions. Recorded music plays continuously regardless of circumstances.
Although music has been used for years in healthcare, the exact mechanisms by which it can reduce pain/anxiety are not well understood. It is known that music can modify emotional state by releasing anti-stress hormones and by activating the limbic system of the brain. According to the gate control theory of pain, distracters such as music can block certain neural pathways and diminish the amount of perceived pain. A systematic review on the use of music in mechanically ventilated adults found that music was associated with lower levels of anxiety, lower sedation requirements, improved vital signs suggesting relaxation, and improved sleep. Whether these observations can also be made in mechanically ventilated, critically ill children remains unclear as there is no literature on the efficacy of utilizing music therapy in this patient population.
Objective(s):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children < 5 years old a
- •Expected mechanical ventilatory support for at least 48 hours after inclusion.
排除标准
- •CNeurocognitive disorder,
- •Admitted post-operatively with an expected length of stay <48 hours,
- •Critical situation where end-of-life care is expected
- •Being deaf or suffer from any other hearing impairment, which would not allow for the Music Intervention to be administered
- •Parents are unable to understand / speak Dutch
研究组 & 干预措施
Live-music therapy
干预措施: Live-music therapy (Behavioral)
Care as usual
结局指标
主要结局
The main study endpoint is patient comfort measured with the Dutch Version of the COMFORT Behavior (COMFORT-B) scale
时间窗: Daily until PICU discharge or up to 28 days, whichever may come first
The Comfort B score is used to assess patient comfort. The Comfort-B scale used in this study is a behavioral clinical scale that consists of six factors: alertness, calmness/agitation, respiratory response (or crying, used in patients with no mechanical ventilation), physical movement, muscle tone, and facial tension.(9) Each factor can be scored with values ranging between 1 and 5, generating scores between 6 and 30 points.
次要结局
- Parental stress levels(Within the first 24 hours of PICU admission, and at PICU discharge or at 28 days whichever may come first)
- Quantification of the degree of DNA methylation of stress-related genes.(Within the first 24 hours of PICU admission, and at PICU discharge or at 28 days whichever may come first)
- Cumulative dose of benzodiazepines, alpha-2-agonists and opioids(Daily until PICU discharge or up to 28 days, whichever may come first)
- Percentage of asynchronous breaths(Daily until PICU discharge or up to 28 days, whichever may come first)
- Heart rate(Daily until PICU discharge or up to 28 days, whichever may come first)
- Respiratory rate(Daily until PICU discharge or up to 28 days, whichever may come first)
- Blood pressure(Daily until PICU discharge or up to 28 days, whichever may come first)
- Brain tissue oxygenation(Daily until PICU discharge or up to 28 days, whichever may come first)
- Abdominal tissue oxygenation(Daily until PICU discharge or up to 28 days, whichever may come first)
- Pressure rate product (PRP)(Daily until PICU discharge or up to 28 days, whichever may come first)
- Pressure time product (PTP)(Daily until PICU discharge or up to 28 days, whichever may come first)
研究者
Martin Kneyber
Prof.dr.
University Medical Center Groningen
