The Effect of Music Therapy as an Adjuvant in the Vital Signs of the Neonate

The admission of a newborn to the neonatal intensive care unit (NICU) represents a potentially harmful sound environment coupled with multiple stressful events. However, a strategy such as music therapy (delivered by a trained music therapist) appears to be a non-invasive, safe, and cost-effective alternative that assists newborns in their physiological self-regulation with a beneficial effect on stabilizing neonatal vital signs, so it can be used as a complementary strategy to medical management. The aim of this study is to determine the effect of live and pre-recorded music therapy on vital sign variables in newborns older than 32 weeks hospitalized in the neonatal intensive care unit of a high-complexity health institution in Colombia.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Disease
• Intervention / Treatment: Other: Music therapy

Detailed Description

A parallel, controlled randomized clinical trial will be conducted.

Study Population: Newborns older than 32 weeks gestational age at birth hospitalized in the Neonatal Intensive Care Unit of a high-complexity health institution who meet the inclusion criteria.

Outcomes: Heart rate will be primary outcome. Respiratory rate and oxygen saturation will be secondary outcomes. The patient monitor will be utilized to measure the heart rate, respiratory rate, and oxygen saturation.

Standardization of measurements:

First, the trademarks of the medical equipment manufacturers of each of the tools that will be used (vital sign monitor and pulse oximeter) will be verified to ensure that they correspond to the same commercial brand. Since different brands may exhibit variability in standard calibration measurements within the critical range, it is important to verify that the tools are of the same brand. Secondly, it will be verified that each medical tool used has been calibrated within the previous six months, with the date of the last calibration recorded so that the device can be used during the study. Subsequently, the professional in charge of the music company will verify that the guitar to be used during the live music is in tune and suitable for use. A decibel regulator will be employed during the implementation of both pre-recorded and live music, adjusting the volume of the emitted sound. This will ensure that the decibels emitted by each research subject remain within the permitted range of 70 decibel (dB). Vital variables will be recorded at minute 0, from minute 0 to minute 10 continuously, and at 30 minutes after the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johana Benavides; Phone Number: 5719901 57-601-5895377; Email: jbenavidescr@unisanitas.edu.co
• Study Contact Backup: Name: Natalia Restrepo; Phone Number: 5719901 57-601-5895377; Email: nrestrepo@unisanitas.edu.co

Study Locations

• Colombia
  • Bogotá, Colombia
    • Recruiting
    • Clínica Universitaria Colombia
    • Contact: Johana Benavides; Email: jbenavidescr@unisanitas.edu.co
    • Sub-Investigator: Diana Clavijo
    • Sub-Investigator: Julián Renza
    • Principal Investigator: Natalia Restrepo
    • Sub-Investigator: Leslie Martínez
    • Sub-Investigator: Johana Benavides

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Newborns with gestational age at birth greater than or equal to 32 weeks.
• Birth weight greater than or equal to 1500 grams.
• Be at least 72 hours of postnatal age.

Exclusion Criteria:

• Respiratory disturbances in the last 48 hours such as: Apnea or Brief Resolved Unexplained Events (BRUE), need for invasive mechanical ventilation
• Hemodynamic alterations in the last 48 hours such as: Hypotension (systolic, diastolic, or mean BP < P5) or hypertension (systolic, diastolic, or mean BP > P95), bradycardia (HR < 100/min), shock of any etiology, requirement for volume expanders, infusion of inotropics, vasodilators and/or prostaglandin E1.
• Neurological alterations such as: Perinatal asphyxia at birth manifested by the need for resuscitation, APGAR < 3 at 5 minutes and/or ≤ 5 at 10 minutes, and metabolic acidosis in cord gases with a potential of hydrogen (pH) < 7 and base excess (BE) < -12, hypoxic-ischemic encephalopathy, seizure syndrome for up to 48 hours after the last clinical event or alteration of the brain pattern, interventricular hemorrhage in preterm infants in the first week of diagnosis.
• Management with Extracorporeal membrane oxygenation (ECMO) and/or nitric oxide
• Temperature less than 36.5 C or greater than 37.5 C.
• Patient under pharmacological sedation or use of beta-blockers.
• Congenital heart disease, operated on or not.
• Congenital malformations
• Surgical emergencies or recovery from a surgical procedure performed within the last 48 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live music; It is performed by a music therapist using the guitar as the only musical instrument. Instrumental lullabies are used, selected by the patient's legal guardian.	Other: Music therapy; Music therapy is a non-pharmacological therapeutic intervention that will be implemented through two modalities: live and pre-recorded instrumental lullabies music.The volume control will be conducted within the groups through the use of a decibel regulator, with a maximum volume of 70 dB. During the intervention and for a period of 30 minutes following its conclusion, singing will be prohibited by the music therapist or the parents. Both live and pre-recorded music will be instrumental in nature, lacking any lyrics.
Experimental: Pre-recorded music; Pre-recorded music of the lullaby genre, instrumental type, using a speaker placed inside the patient's incubator.	Other: Music therapy; Music therapy is a non-pharmacological therapeutic intervention that will be implemented through two modalities: live and pre-recorded instrumental lullabies music.The volume control will be conducted within the groups through the use of a decibel regulator, with a maximum volume of 70 dB. During the intervention and for a period of 30 minutes following its conclusion, singing will be prohibited by the music therapist or the parents. Both live and pre-recorded music will be instrumental in nature, lacking any lyrics.
No Intervention: Control; There will be no musical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	The measurement will be continuously quantified in terms of number of pulsations per minute continuously.	The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	The measurement will be continuously quantified in terms of the number of breaths per minute.	The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.
Oxygen saturation	The measurement will be continuously quantified in terms of proportion per minute.	The baseline measurement will be taken before the intervention, and will continue for 30 minutes during the intervention and for a further 30 minutes after the intervention has been completed.

Collaborators and Investigators

• Sponsor: Claudia Aristizábal
• Collaborators: Sanitas University
• Investigators: Study Director: Johana Benavides, MSc, Unisanitas

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Actual): July 18, 2024
• Study Completion (Estimated): July 18, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: CEIFUS 470-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: When the study ends, individual participant data could be shared with the approval of the research ethics committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No