Music as Intervention Nursing in Ambulances

December 8, 2022 updated by: María Ángeles Gregorio Sanz, Universidad Miguel Hernandez de Elche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention group underwent exposure to relaxing music with sounds from nature
Other: Music Intervention
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
No Intervention: Control
The control group under the usual transfer conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SBP
Time Frame: 20 minutes
Systolic Blood Pressure (mm Hg)
20 minutes
DBP
Time Frame: 20 minutes
Diastolic Blood Pressure (mm Hg)
20 minutes
HR
Time Frame: 20 minutes
Heart Rate (beats per minute)
20 minutes
RR
Time Frame: 20 minutes
Respiratory Rate (breaths per minute)
20 minutes
SpO2
Time Frame: 20 minutes
Oxigen Saturation (%)
20 minutes
EtCO2
Time Frame: 20 minutes
Exhaled Carbon Dioxide (%)
20 minutes
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.
20 minutes
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.
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nitrates/Antiarrhythmics
Time Frame: up to 4 hours
drugs administered transfer (Yes/No)
up to 4 hours
Opioids
Time Frame: up to 4 hours
drugs administered transfer (Yes/No)
up to 4 hours
Antiemetics
Time Frame: up to 4 hours
drugs administered transfer (Yes/No)
up to 4 hours
Benzodiazepines
Time Frame: up to 4 hours
drugs administered transfer (Yes/No)
up to 4 hours
Tenecteplase
Time Frame: up to 4 hours
drugs administered transfer (Yes/No)
up to 4 hours
Enoxoparin
Time Frame: up to 4 hours
drugs administered transfer (Yes/No)
up to 4 hours
Furosemide
Time Frame: up to 4 hours
drugs administered transfer (Yes/No)
up to 4 hours
Ranitidine
Time Frame: up to 4 hours
drugs administered transfer (Yes/No)
up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Investigators

  • Principal Investigator: MARIA ANGELES GREGORIO-SANZ, Master, Universidad Miguel Hernández

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23UMH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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