Music as Analgesia During Neonatal Circumcision

Music as an Adjunct to Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial

Neonatal circumcision is one of the most frequently performed and more painful procedures. Sharara et al (2017) showed the combination of EMLA + Sucrose + Ring Block provides the highest standard of pain management. A combination which has been adopted by practitioners who perform circumcisions at the normal nursery at AUBMC. An element which is overlooked in its ability to enhance or suppress stress and consequently pain is sound/noise, music. The specific aim of this study is to test the added effectiveness of music (Group B: intervention) to the established standard for analgesia [EMLA + Sucrose + Ring Block] (Group A: control) in further managing the pain of newborn males undergoing circumcision.

Study Overview

• Status: Unknown
• Conditions: Analgesia
• Intervention / Treatment: Other: Music

Detailed Description

Scientific Context: Neonatal circumcision is one of the most frequently performed and more painful procedures. Sharara et al (2017) showed the combination of EMLA + Sucrose + Ring Block provides the highest standard of pain management. A combination which has been adopted by practitioners who perform circumcisions at the normal nursery at AUBMC. An element which is overlooked in its ability to enhance or suppress stress and consequently pain is sound/noise, music.

Hypothesis/Aims: The specific aim of this study is to test the added effectiveness of music (intervention) to EMLA + Sucrose + Ring Block (control group) in further managing the pain of newborn males undergoing circumcision.

Experimental design, subject selection/recruitment, procedures involving human subjects: A double blinded randomized controlled trial, comparing the control Group A to the intervention Group B: Music. All healthy, late pre-term and term (36-41 weeks) newborn males admitted to the normal nursery at the AUBMC whose parents request circumcision are eligible for recruitment following a negative auditory screening test. Following written consent from the parents, participants will be allocated to either control or intervention based on a prepared list of block randomization. Babies will be videotaped during the circumcision, legs and the field of operation will be excluded from view. This video will be evaluated by two blinded pediatricians using the validated Neonatal Infant Pain Scale/Score (NIPS).

4- Risks and Benefits, and Risk/Benefit Ratio: The risks are associated with the circumcision procedure itself, not the proposed intervention, these risks are rare and may include risks associated with the surgery, or adverse reactions to the pharmacological anesthetics administered. Benefits include maximal pain management. The ratio leans favorably towards the benefits.

Privacy and Confidentiality: All Co-investigators are blinded to the randomization. Babies will be marked as Baby 1, Baby 2, and Baby 3…etc. The videotaping will not include any identifying information, although the baby's face will be in view; the videos will be placed on a password protected IPad only used for the purposes of this study, in the study coordinator's possession, kept in a locked drawer. When evaluating these videos, the evaluators will view them on the IPad. No copies or duplicates will be made and shared, even among the team. The collected data will be coded and kept on a password protected computer, the coded file will be shared with the statistician for the purposes of analysis. Following IRB protocol, all study related materials will be destroyed and permanently deleted after 3 years from the completion of the study.

• Study Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zavi Lakissian, MD, MPH, PgD; Phone Number: 5521 009611350000; Email: zl00@aub.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon, 1107 2020
    • Recruiting
    • American University of Beirut Medical Center
    • Sub-Investigator: Lama Charafeddine, MD
    • Contact: Rana Sharara-Chami, MD; Phone Number: 5536 009611350000; Email: rsharara@aub.edu.lb
    • Sub-Investigator: Ahmad Zaghal, MD
    • Sub-Investigator: Yaser El-Hout, MD
    • Sub-Investigator: Hani Tamim, PhD
    • Principal Investigator: Rana Sharara-Chami, MD
    • Sub-Investigator: Vicky Tazian, RN
    • Sub-Investigator: Zavi Lakissian, MD, MPH, PgD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• All healthy, late pre-term and term (36-41 weeks) newborn males admitted to the normal nursery at the American University of Beirut Medical Center (AUBMC) who have successfully passed an auditory screening (including the AABR and/or OAE) and whose parents request circumcision are eligible for recruitment

Exclusion Criteria:

• Newborn males admitted to the normal nursery at the American University of Beirut Medical Center (AUBMC), who have not passed the auditory screening (including the AABR and/or OAE).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; This arm represents the control group. They will be undergoing the circumcision without any music, with the established standard for analgesia [EMLA+Sucrose+Ring Block]
Experimental: Group B: Music; In addition to the standard analgesia as explained for group A, Music will be played from the "Baby Go to Sleep" playlist which includes nursery rhymes and lullabies metonymized to an actual human heartbeat (Houser, 1994). Music will start after the baby settles on the board and before the surgeon starts the procedure.	Other: Music; Studies have been conducted to assess the effects of sound and noise on neonatal stress. Recently, music is being used in neonatal units to improve physiological and behavioral outcomes (Harling et al, 2009). Of the few studies done on the effectiveness of music during circumcision is a randomized double-blinded controlled trial conducted by Joyce et al (2001): it found that some physiologic outcomes were significantly lower among the music group in comparison to the EMLA group. They concluded that there is preliminary evidence to support the efficacy of EMLA and music in pain management of newborn circumcision; however, more rigorous studies are warranted for conclusive results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Infant Pain Scale (NIPS)	The NIPS is a non-intrusive, replicable, and objective tool for assessing pain responses. The tool uses five behavioral cues observed over time, with a composite score of 0 to 6, to determine the amount of pain or change in pain the infant is experiencing; scores more than 3 are indicative of pain.	4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	The infant is placed on a pulse oximeter during the circumcision to monitor his heart rate.	4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Oxygen Saturation	The infant is placed on a pulse oximeter during the circumcision to monitor his oxygen saturation.	4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Crying Time	The assistant will be timing the infant's crying during the circumcision, as an indicator of pain.	4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Rana Sharara-Chami, MD, American University of Beirut Medical Center

Publications and helpful links

General Publications

• Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
• Sharara-Chami et al. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial. Pediatrics. 2017;140(6):e20171935. Pediatrics. 2018 May;141(5):e20180500. doi: 10.1542/peds.2018-0500. Epub 2018 Apr 30. No abstract available.
• Sharara-Chami R, El-Hout Y, Lakissian Z, Hafez B, Abi-Gerges C, Fayad J, Charafeddine L, Tazian V, Tamim H, Zaghal A. Music as an adjunct to combination analgesia for neonatal circumcision: A randomized controlled trial. J Pediatr Urol. 2022 Apr;18(2):184.e1-184.e6. doi: 10.1016/j.jpurol.2021.12.011. Epub 2021 Dec 24.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Music; Neonatal Circumcision
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: BIO-2018-0405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is only to be shared within the investigating team. The results will be shared in aggregate form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No