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

NCT ID: NCT06408064

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-03
• Study Completion Date: 2024-07-18

Brief Summary

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.

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.

Conditions

Neonatal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: OTHER

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.

Pre-recorded music

Pre-recorded music of the lullaby genre, instrumental type, using a speaker placed inside the patient's incubator.

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: OTHER

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.

Control

There will be no musical intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 40 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanitas University

OTHER

Sponsor Role: collaborator

Claudia Aristizábal

OTHER

Sponsor Role: lead

Responsible Party

Claudia Aristizábal

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johana Benavides, MSc

Role: STUDY_DIRECTOR

Unisanitas

Locations

Clínica Universitaria Colombia

Bogotá, , Colombia

Countries

Colombia

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CEIFUS 470-24

Identifier Type: -

Identifier Source: org_study_id