Music Therapy for Pain Management for Minor Procedures in Neonates.

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04313179
• Other study ID #: IRB#18-026
• Status: Terminated
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: March 2021
• Source: New York City Health and Hospitals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 37 Weeks to 42 Weeks

Eligibility

Inclusion Criteria:

• >37 weeks gestation babies

Exclusion Criteria:

• <37 weeks gestation babies

• Major congenital anomalies

• Failed hearing screen

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Music therapy
Mozart lullaby music
• Sucrose
0.5 ml of 24% Sucrose

Locations

Country	Name	City	State
United States	Lincoln Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York City Health and Hospitals Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3). pii: e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in NIPS scoring by 20%	A score greater than 3 indicates pain, maximum score is 7 and minimum is 0	5 minutes post procedure