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Clinical Trials/NCT05399927
NCT05399927CompletedNot Applicable

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

Universidad Miguel Hernandez de Elche0 sites41 target enrollmentStarted: July 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Primary Endpoint
SpO2

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Control

No Intervention

The control group under the usual transfer conditions.

Intervention

Experimental

The intervention group underwent exposure to relaxing music with sounds from nature

Intervention: Music Intervention (Other)

Outcomes

Primary Outcomes

SpO2

Time Frame: 20 minutes

Oxigen Saturation (%)

SBP

Time Frame: 20 minutes

Systolic Blood Pressure (mm Hg)

DBP

Time Frame: 20 minutes

Diastolic Blood Pressure (mm Hg)

RR

Time Frame: 20 minutes

Respiratory Rate (breaths per minute)

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.

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.

HR

Time Frame: 20 minutes

Heart Rate (beats per minute)

EtCO2

Time Frame: 20 minutes

Exhaled Carbon Dioxide (%)

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

María Ángeles Gregorio Sanz

Principal Investigator

Universidad Miguel Hernandez de Elche

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