Skip to main content
OpenTrials
Completed

NCT Number: NCT05399927

Music as Intervention Nursing in Ambulances

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

The qualitative variables have been summarized using counts and percentages. The mean and standard deviation were used to summarize the quantitative variables. The Kolmogorov-Smirnov test was employed to verify the hypothesis of normality. Depending on the test result, a parametric test (t test for two independent samples) or a non-parametric test (Mann-Whitney U test) was used. For qualitative variables, the Chi-square test or Fisher's exact test were used according to the fulfillment of the approximation conditions. An adjusted multivariate logistic regression model was used to try to characterize the patients in each of the groups considered. For its construction, those variables that presented a p-value <0.10 in the univariate study have been considered. The ODDS Ratio and its corresponding 95% confidence interval were calculated. To validate the model, the Hosmer and Lemeshow (HL) goodness of fit test was performed. Nagelkerke's R2 coefficient was used to estimate the proportion of the explained variance. The precision of the model was evaluated using the area under the curve (AUC). A p-value of less than 0.05 was considered significant. The analyses were performed with the IBM SPSS v25 statistical package.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Music intervention

Other

The objective of this study is to observe the effects that music produces on physiological parameters, in patients with Acute Cardiovascular Disease (ACVD), and to determine its influence on the types or doses of drugs administered during initial care. The intervention study is carried out in the ambulance cabin during the time of transfer to the destination Hospital.

Other names: Music Therapy

Primary outcomes

  1. SBP

    Time frame: 20 minutes

    Systolic Blood Pressure (mm Hg)

  2. DBP

    Time frame: 20 minutes

    Diastolic Blood Pressure (mm Hg)

  3. HR

    Time frame: 20 minutes

    Heart Rate (beats per minute)

  4. RR

    Time frame: 20 minutes

    Respiratory Rate (breaths per minute)

  5. SpO2

    Time frame: 20 minutes

    Oxigen Saturation (%)

  6. EtCO2

    Time frame: 20 minutes

    Exhaled Carbon Dioxide (%)

  7. VAS

    Time frame: 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.

  8. BIS

    Time frame: 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.

Secondary outcomes

  1. Nitrates/Antiarrhythmics

    Time frame: up to 4 hours

    drugs administered transfer (Yes/No)

  2. Opioids

    Time frame: up to 4 hours

    drugs administered transfer (Yes/No)

  3. Antiemetics

    Time frame: up to 4 hours

    drugs administered transfer (Yes/No)

  4. Benzodiazepines

    Time frame: up to 4 hours

    drugs administered transfer (Yes/No)

  5. Tenecteplase

    Time frame: up to 4 hours

    drugs administered transfer (Yes/No)

  6. Enoxoparin

    Time frame: up to 4 hours

    drugs administered transfer (Yes/No)

  7. Furosemide

    Time frame: up to 4 hours

    drugs administered transfer (Yes/No)

  8. Ranitidine

    Time frame: up to 4 hours

    drugs administered transfer (Yes/No)

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2022
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.