Music Therapy for Pain Management for Minor Procedures in Neonates.
NCT04313179 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2021-03-16
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.
Conditions
Interventions
- OTHER
-
Music therapy
Mozart lullaby music
- OTHER
-
Sucrose
0.5 ml of 24% Sucrose
Sponsors & Collaborators
-
New York City Health and Hospitals Corporation
lead OTHER
Principal Investigators
-
Prathiba Ankola, MD · Lincoln Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 37 Weeks
- Max Age
- 42 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-09
- Primary Completion
- 2020-02-25
- Completion
- 2020-02-25
Countries
- United States
Study Locations
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