Music Therapy for Pain Management for Minor Procedures in Neonates.

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Music therapy
* Other: Sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >37 weeks gestation babies Exclusion Criteria: <37 weeks gestation babies Major congenital anomalies Failed hearing screen

Ages Eligible for Study
-----------------
Minimum Age: 37 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music group<br>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 therapy<br>* Mozart lullaby music<br>Other: Sucrose<br>* 0.5 ml of 24% Sucrose<br>|
| Placebo Comparator: Placebo group<br>0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure. No music played. | Other: Sucrose<br>* 0.5 ml of 24% Sucrose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal pain, Music therapy