Music as Intervention Nursing in Ambulances
Primary Purpose
Music Therapy, Cardiovascular Diseases, Critical Care
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music Intervention
Sponsored by

About this trial
This is an interventional supportive care trial for Music Therapy focused on measuring Cardiovascular Disease, Music Therapy, Emergency Mobile Unit, Critical Care Nursing, Statistical comparison.
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
The intervention group underwent exposure to relaxing music with sounds from nature
The control group under the usual transfer conditions.
Outcomes
Primary Outcome Measures
SBP
Systolic Blood Pressure (mm Hg)
DBP
Diastolic Blood Pressure (mm Hg)
HR
Heart Rate (beats per minute)
RR
Respiratory Rate (breaths per minute)
SpO2
Oxigen Saturation (%)
EtCO2
Exhaled Carbon Dioxide (%)
VAS
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.
BIS
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 Outcome Measures
Nitrates/Antiarrhythmics
drugs administered transfer (Yes/No)
Opioids
drugs administered transfer (Yes/No)
Antiemetics
drugs administered transfer (Yes/No)
Benzodiazepines
drugs administered transfer (Yes/No)
Tenecteplase
drugs administered transfer (Yes/No)
Enoxoparin
drugs administered transfer (Yes/No)
Furosemide
drugs administered transfer (Yes/No)
Ranitidine
drugs administered transfer (Yes/No)
Full Information
NCT ID
NCT05399927
First Posted
March 26, 2022
Last Updated
December 8, 2022
Sponsor
Universidad Miguel Hernandez de Elche
1. Study Identification
Unique Protocol Identification Number
NCT05399927
Brief Title
Music as Intervention Nursing in Ambulances
Official Title
"Effects of Music Intervention Nursing in Advanced Life Support Ambulances: a Randomised Trial"
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Therapy, Cardiovascular Diseases, Critical Care, Emergencies
Keywords
Cardiovascular Disease, Music Therapy, Emergency Mobile Unit, Critical Care Nursing, Statistical comparison.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group underwent exposure to relaxing music with sounds from nature
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group under the usual transfer conditions.
Intervention Type
Other
Intervention Name(s)
Music Intervention
Other Intervention Name(s)
Music Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
SBP
Description
Systolic Blood Pressure (mm Hg)
Time Frame
20 minutes
Title
DBP
Description
Diastolic Blood Pressure (mm Hg)
Time Frame
20 minutes
Title
HR
Description
Heart Rate (beats per minute)
Time Frame
20 minutes
Title
RR
Description
Respiratory Rate (breaths per minute)
Time Frame
20 minutes
Title
SpO2
Description
Oxigen Saturation (%)
Time Frame
20 minutes
Title
EtCO2
Description
Exhaled Carbon Dioxide (%)
Time Frame
20 minutes
Title
VAS
Description
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.
Time Frame
20 minutes
Title
BIS
Description
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Nitrates/Antiarrhythmics
Description
drugs administered transfer (Yes/No)
Time Frame
up to 4 hours
Title
Opioids
Description
drugs administered transfer (Yes/No)
Time Frame
up to 4 hours
Title
Antiemetics
Description
drugs administered transfer (Yes/No)
Time Frame
up to 4 hours
Title
Benzodiazepines
Description
drugs administered transfer (Yes/No)
Time Frame
up to 4 hours
Title
Tenecteplase
Description
drugs administered transfer (Yes/No)
Time Frame
up to 4 hours
Title
Enoxoparin
Description
drugs administered transfer (Yes/No)
Time Frame
up to 4 hours
Title
Furosemide
Description
drugs administered transfer (Yes/No)
Time Frame
up to 4 hours
Title
Ranitidine
Description
drugs administered transfer (Yes/No)
Time Frame
up to 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA ANGELES GREGORIO-SANZ, Master
Organizational Affiliation
UNIVERSIDAD MIGUEL HERNANDEZ
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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