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临床试验/NCT05399927
NCT05399927已完成不适用

"Effects of Music Intervention Nursing in Advanced Life Support Ambulances: a Randomised Trial"

Universidad Miguel Hernandez de Elche0 个研究点目标入组 41 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
主要终点
SpO2

研究概览

简要总结

Background: Patients with acute cardiovascular disease require out-of-hospital care during the most critical and vulnerable periods of their illness.

Objectives: To evaluate the influence of music intervention in patients with an acute cardiovascular condition during their transfer in Advanced Life Support (ALS) ambulances.

Method: A controlled, randomized experimental analytical study of cases and controls. The intervention group was exposed to relaxing music with sounds from nature. Data related to demographic factors, comorbidities, clinical constants, and drugs administered were gathered. The qualitative variables were summarized using counts and percentages, and the quantitative variables through means and standard deviations.

详细描述

Out-of-hospital Emergency Services are characterized by providing urgent health care, to patients in critical health circumstances, at the place where the event occurs. This fact means that the Advanced Life Support (ALS) ambulances are present when the patient presents a higher degree of stress and, therefore, where greater changes can be found at the physiological level. This is reflected in alterations in the vital signs, which a can increase the pathophysiological effects, as the patient is placed in a hostile and unfamiliar environment, such as the ambulance cabin, surrounded by noises produced by the electromedical equipment and the circumstances of the transport itself (sirens, potholes, speed bumps, ...).

In a cabin with these characteristics, the patient may feel claustrophobic, an effect that can be enhanced by the limitation of movement generated by the anchoring of the seat belts to the stretcher and the lack of family support.

The implementation of ALS is relatively young, hence research in this emerging field, has been scarce in scientific production in the discipline of emergencies compared with other specialties in Spain Data were collected with regard to demographic data (age and gender), medical diagnosis, systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), respiratory rate (RR), partial oxygen saturation (SpO2), the concentration of carbon dioxide at the end of exhalation (EtCO2), the pain perceived by means of the visual analog scale (VAS), the bispectral index (BIS) and the temperature (T) every 15 minutes during the transfer.

Data related to administered drugs were also collected, grouped into: antiarrhythmics, antiemetics and opioids. In order to facilitate the collection and recording of data, the nursing report of Castilla La Mancha's Management of Emergencies and Medical Transport (GUETS) has been used, to which the parameters that are not usually collected are routinely added, such as the BIS and EtCO2. For the measurement of vital signs, a manual defibrillator of the Zoll® E-series brand was used. Temperature was recorded with a WelchAllyn brand Sure Temp® PLUS thermometer, the ambient temperature was maintained at around 22-23ºC for comfort. Hypnosis and pain level data were obtained with the BIS VISTA ™ Monitoring System.

The music system used was a BTS dynamic mini speaker, model MS109. The decibels were measured in the passenger cabin during the transfer, being in a range of 48.6 - 59.5 dB reaching a maximum of 73.1 dB when driving over a speed bump, and a maximum of 77.7 dB when putting on the sirens. Consequently, the volume was adjusted between 65-70 dB, to mask the usual sounds of the cabin.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • be of legal age,
  • being aware and oriented in time-space,
  • person with signs and symptoms of ACVD transferred in an ALS ambulance for at least 20 minutes.

排除标准

  • patients with non-physiological bradycardia,
  • patients with severe sensory auditory deficiency,
  • patients with psychiatric pathology.

结局指标

主要结局

SpO2

时间窗: 20 minutes

Oxigen Saturation (%)

SBP

时间窗: 20 minutes

Systolic Blood Pressure (mm Hg)

DBP

时间窗: 20 minutes

Diastolic Blood Pressure (mm Hg)

RR

时间窗: 20 minutes

Respiratory Rate (breaths per minute)

BIS

时间窗: 20 minutes

Bispectral Index (0 to 100) :0 flat-line EEG; 0-40 Deep hypnotic state; 41-60 anesthesia range; 61-90 sedation range; 91-100 awake.

VAS

时间窗: 20 minutes

Visual Analog Scale (0 to 10): 0 no pain; 1-2 slight pain; 3-4 mild pain; 5-6 moderate pain; 7-8 severe pain and 10 horrible pain.

HR

时间窗: 20 minutes

Heart Rate (beats per minute)

EtCO2

时间窗: 20 minutes

Exhaled Carbon Dioxide (%)

次要结局

  • Enoxoparin(up to 4 hours)
  • Antiemetics(up to 4 hours)
  • Benzodiazepines(up to 4 hours)
  • Tenecteplase(up to 4 hours)
  • Ranitidine(up to 4 hours)
  • Nitrates/Antiarrhythmics(up to 4 hours)
  • Opioids(up to 4 hours)
  • Furosemide(up to 4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Ángeles Gregorio Sanz

Principal Investigator

Universidad Miguel Hernandez de Elche

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Music as Intervention Nursing in Ambulances | 临床试验