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

NCT06408064 | Completed DMC

• 1 other identifier: CEIFUS 470-24
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Respiratory rate

  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 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.

Study Arms (3)

Live music

EXPERIMENTAL

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

Pre-recorded music

EXPERIMENTAL

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

Other: Music therapy

Control

NO INTERVENTION

There will be no musical intervention.

Interventions

Music therapy 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.

Live music; Pre-recorded music

Eligibility Criteria

• Age: 32 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Claudia Aristizábal: lead
• Sanitas University: collaborator

Study Sites (1)

Clínica Universitaria Colombia

Bogotá, Colombia

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Johana Benavides, MSc

  Unisanitas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Music therapy is a non-pharmacological therapeutic intervention that will be implemented through two modalities: live and pre-recorded music. Group A will be that of patients exposed to live music, which will be carried out by a music therapist using the guitar as the only musical instrument. Instrumental lullabies will be used, which will be selected by the patients' legal guardians. Group B corresponds to patients who will be exposed to pre-recorded music, of the genre of lullabies, instrumental type, using a speaker that will be placed inside the patient's incubator. Group C will be those patients in whom no musical intervention will be performed.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 9, 2024
• Study Start: May 3, 2024
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)