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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
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 26, 2022
    Last Updated
    December 8, 2022
    Sponsor
    Universidad Miguel Hernandez de Elche
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    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
    Citations:
    PubMed Identifier
    26277246
    Citation
    Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12. Erratum In: Lancet. 2015 Oct 24;386(10004):1630.
    Results Reference
    background
    PubMed Identifier
    27096963
    Citation
    do Amaral MA, Neto MG, de Queiroz JG, Martins-Filho PR, Saquetto MB, Oliveira Carvalho V. Effect of music therapy on blood pressure of individuals with hypertension: A systematic review and Meta-analysis. Int J Cardiol. 2016 Jul 1;214:461-4. doi: 10.1016/j.ijcard.2016.03.197. Epub 2016 Apr 3.
    Results Reference
    background
    PubMed Identifier
    29665028
    Citation
    Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
    Results Reference
    background
    PubMed Identifier
    26835471
    Citation
    Heidari S, Babaii A, Abbasinia M, Shamali M, Abbasi M, Rezaei M. The Effect of Music on Anxiety and Cardiovascular Indices in Patients Undergoing Coronary Artery Bypass Graft: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Dec;4(4):e31157. doi: 10.17795/nmsjournal31157. Epub 2015 Dec 1.
    Results Reference
    background
    PubMed Identifier
    27235956
    Citation
    McClurkin SL, Smith CD. The Duration of Self-Selected Music Needed to Reduce Preoperative Anxiety. J Perianesth Nurs. 2016 Jun;31(3):196-208. doi: 10.1016/j.jopan.2014.05.017. Epub 2016 Feb 24.
    Results Reference
    background
    PubMed Identifier
    21372737
    Citation
    Chang HK, Peng TC, Wang JH, Lai HL. Psychophysiological responses to sedative music in patients awaiting cardiac catheterization examination: a randomized controlled trial. J Cardiovasc Nurs. 2011 Sep-Oct;26(5):E11-8. doi: 10.1097/JCN.0b013e3181fb711b.
    Results Reference
    background
    PubMed Identifier
    26817929
    Citation
    Ng MY, Karimzad Y, Menezes RJ, Wintersperger BJ, Li Q, Forero J, Paul NS, Nguyen ET. Randomized controlled trial of relaxation music to reduce heart rate in patients undergoing cardiac CT. Eur Radiol. 2016 Oct;26(10):3635-42. doi: 10.1007/s00330-016-4215-8. Epub 2016 Jan 27.
    Results Reference
    background
    PubMed Identifier
    26764267
    Citation
    Tam WW, Lo KK, Hui DS. The effect of music during bronchoscopy: A meta-analysis. Heart Lung. 2016 Mar-Apr;45(2):86-94. doi: 10.1016/j.hrtlng.2015.12.004. Epub 2016 Jan 4.
    Results Reference
    background
    PubMed Identifier
    24374731
    Citation
    Bradt J, Dileo C, Potvin N. Music for stress and anxiety reduction in coronary heart disease patients. Cochrane Database Syst Rev. 2013 Dec 28;2013(12):CD006577. doi: 10.1002/14651858.CD006577.pub3.
    Results Reference
    background
    PubMed Identifier
    27912960
    Citation
    Liang Z, Ren D, Choi J, Happ MB, Hravnak M, Hoffman LA. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial. Complement Ther Med. 2016 Dec;29:72-77. doi: 10.1016/j.ctim.2016.09.003. Epub 2016 Sep 15.
    Results Reference
    background
    PubMed Identifier
    19522258
    Citation
    Maeyama A, Kodaka M, Miyao H. [Effect of the music-therapy under spinal anesthesia]. Masui. 2009 Jun;58(6):684-91. Japanese.
    Results Reference
    background
    PubMed Identifier
    31121392
    Citation
    Gramaglia C, Gambaro E, Vecchi C, Licandro D, Raina G, Pisani C, Burgio V, Farruggio S, Rolla R, Deantonio L, Grossini E, Krengli M, Zeppegno P. Outcomes of music therapy interventions in cancer patients-A review of the literature. Crit Rev Oncol Hematol. 2019 Jun;138:241-254. doi: 10.1016/j.critrevonc.2019.04.004. Epub 2019 Apr 5.
    Results Reference
    background
    PubMed Identifier
    23298702
    Citation
    Sanjuan Navais M, Via Clavero G, Vazquez Guillamet B, Moreno Duran AM, Martinez Estalella G. [Effect of music on anxiety and pain in patients with mechanical ventilation]. Enferm Intensiva. 2013 Apr-Jun;24(2):63-71. doi: 10.1016/j.enfi.2012.11.003. Epub 2013 Jan 5. Spanish.
    Results Reference
    background

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