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

NCT06408064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sanitas University

    collaborator OTHER

  • Claudia Aristizábal

    lead OTHER

Principal Investigators

  • Johana Benavides, MSc · Unisanitas

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2024-07-18
Completion
2024-07-18

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06408064 on ClinicalTrials.gov