NCT04313179

Music Therapy for Pain Management for Minor Procedures in Neonates.

Music Therapy as an Adjuvant Therapy for Pain Management During Heel Prick Procedures in Term Neonates.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: New York City Health and Hospitals Corporation · Academic / Other
• Sex: All
• Age: 37 Weeks – 42 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	Music therapy	Mozart lullaby music
OTHER	Sucrose	0.5 ml of 24% Sucrose

Timeline

• Start date: 2019-04-09
• Primary completion: 2020-02-25
• Completion: 2020-02-25
• First posted: 2020-03-18
• Last updated: 2021-03-16

Locations

1 site across 1 country: United States