Effect of music on stress in preterm neonates
Investigation of the Effect of Music on the Stress of Preterm Neonates Through Innovative Applications
This study is testing whether playing music can help reduce stress in preterm babies in the NICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 28 Weeks to 37 Weeks |
| Sex | All |
| Sponsor | University of West Attica Academic / other |
| Locations | 2 sites (Athens and 1 other locations) |
| Trial ID | NCT06650189 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how music intervention can reduce stress levels in preterm neonates admitted to a Neonatal Intensive Care Unit (NICU). The study involves a randomized controlled design where participants will be assigned to either a music intervention group or a control group without music. Over five consecutive days, the neonates in the intervention group will be exposed to recorded music while their salivary biomarkers will be measured to assess stress levels. The aim is to determine if music can positively impact the stress response in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm neonates born between 28 and 36 weeks of gestation who are in a stable clinical condition.
Not a fit: Patients with active infections, congenital disorders, or those who experience clinical deterioration may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce stress in preterm neonates, potentially improving their overall health outcomes.
How similar studies have performed: While the use of music therapy in various settings has shown promise, this specific approach in preterm neonates is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Born between 28 - 36+6 weeks of gestation * Absence of active infection including blood, urine, cerebrospinal fluid * Absence of congenital and genetic disorders and chromosomal abnormalities * Absence of nuclear jaundice * Absence of endocrine disorders * Absence of maternal use of illicit drugs prenatally * Non - sedated neonates * Positive bilateral transient evoked otoacoustic emissions * Stable clinical condition * Absence of brain injury Exclusion Criteria: * Diagnosis of brain injury after the enrollment * Negative auditory brainstem response before discharge * Clinical deterioration
Where this trial is running
Athens and 1 other locations
- General and Maternity Hospital of Athens Elena Venizelou — Athens, Greece (Recruiting)
- Attikon General University Hospital — Chaïdári, Greece (Not_yet_recruiting)
Study contacts
- Study coordinator: Dimitra Metallinou, Assistant Professor
- Email: dmetallinou@uniwa.gr
- Phone: 2105387410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.