An interventional study of Music therapy in Neonatal Disease, sponsored by Claudia Aristizábal. Completed at 1 site in Colombia. Open to participants aged 32 Weeks to 40 Weeks. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Claudia Aristizábal · Not applicable, Interventional, and Other
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.
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.
134 studies on the registry are indexed under Infant, Newborn, Diseases; 30 are open to participants now.
This study's enrollment of 45 is below the median of 72 across 81 interventional studies indexed under Infant, Newborn, Diseases.
Browse Infant, Newborn, Diseases studies →Claudia Aristizábal is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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 of the lullaby genre, instrumental type, using a speaker placed inside the patient's incubator.
Other: Music therapy
There will be no musical intervention.
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.
Heart rate
The measurement will be continuously quantified in terms of number of pulsations per minute continuously.
Time frame: 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.
Respiratory rate
The measurement will be continuously quantified in terms of the number of breaths per minute.
Time frame: 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.
Time frame: 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.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — When the study ends, individual participant data could be shared with the approval of the research ethics committee.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Claudia Aristizábal