NCT04313179

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

March 9, 2020

Last Update Submit

March 11, 2021

Conditions

Pain

Keywords

Neonatal painMusic therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Music group

EXPERIMENTAL

"Deep Sleep" music track from "Bedtime Mozart: Classical Lullabies for Babies", played through smart phone speakers, at maximum sound up to 45 dB, starting 20 minutes before the heel prick procedure, continuing through the procedure and for 5 minutes after the procedure. Also given 0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure for baseline pain relief.

Other: Music therapyOther: Sucrose

Placebo group

PLACEBO COMPARATOR

0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure. No music played.

Other: Sucrose

Interventions

Music therapyOTHER

Mozart lullaby music

Music group
SucroseOTHER

0.5 ml of 24% Sucrose

Music groupPlacebo group

Eligibility Criteria

Age37 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \>37 weeks gestation babies

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lincoln Medical Center

The Bronx, New York, 10451, United States

Location

Related Publications (3)

  • 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.

    PMID: 22908052BACKGROUND

  • 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.

    PMID: 27561729BACKGROUND

  • 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.

    PMID: 29428919BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Music TherapySucrose

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Prathiba Ankola, MD

    Lincoln Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Neonatologist

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 18, 2020

Study Start

April 9, 2019

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

US(1)