Clinical trial NCT04313179: Music Therapy for Pain Management for Minor Procedures in Neonates.
Official title: Music Therapy as an Adjuvant Therapy for Pain Management During Heel Prick Procedures in Term Neonates.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Neonatal pain
Music therapy
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effectiveness and safety of music therapy as adjuvant therapy for pain management in newborns undergoing minor painful procedures. It is a prospective study and we plan to enroll 200 healthy full term newborns undergoing minor procedures (heel pricks). They will be randomly assigned to either control or music group. Those in music group will receive recorded Mozart lullaby music. Pain will be assessed using NIPS (Neonatal Infant Pain Scale) scoring tool. The potential benefit of the study would be identifying music a safe and efficient adjuvant therapy for pain management in newborns.

Detailed description: This randomized, controlled, double blinded, clinical trial will include full term neonates undergoing painful minor procedures (heel pricks) in the Nursery unit of Lincoln Medical and Mental Health Center.

One of the investigators involved in the study will obtain consent from the legal guardian and enroll the participants. All infants, regardless of the group that they are assigned, will receive similar standard non-pharmacologic method of pain relief which is 0.5 ml of 24% Sucrose, 2 minutes before undergoing heel prick. Pacifiers will be avoided to avoid potential confounding.

Subjects will be randomized into two different groups. Group A, music intervention group and group B, control group. In the music intervention group, a recorded instrumental lullaby music track called "Deep Sleep" from "Bedtime Mozart: Classical Lullabies for Babies", will be played for the neonates through smart phone speakers (maximum sound up to 60 A dB), starting 20 minutes before the heel prick, continuing through the procedure and for 5 minutes after the procedure. This music track has been selected based on previous research studies that showed effectiveness in neonatal pain management.

An investigator involved in the study will place the baby in a bassinet in a quite, dim lighted room. He/She will play the music for those babies in the music group and will NOT assess the NIPS. Another investigator wearing active noise cancelling Bluetooth headphones (for blinding) will enter the room at 5 minutes prior to the procedure and assess the NIPS at appropriate intervals: 5 minutes prior and at 1-minute interval during and after the procedure for 5 minutes. NIPS will be compared using appropriate statistical methods.

Eligibility criteria: Inclusion Criteria:

* \>37 weeks gestation babies

Exclusion Criteria:

* \<37 weeks gestation babies
* Major congenital anomalies
* Failed hearing screen

Primary outcomes:
measure: Reduction in NIPS scoring by 20%
timeFrame: 5 minutes post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Medical Center
state: New York
Study officials:
affiliation: Lincoln Medical Center
name: Prathiba Ankola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Standley J. Music therapy research in the NICU: an updated meta-analysis. Neonatal Netw. 2012 Sep-Oct;31(5):311-6. doi: 10.1891/0730-0832.31.5.311.
citation: Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
citation: Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, Nimbalkar S. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2018 Apr 15;55(4):292-296. Epub 2018 Feb 9.