Music as Analgesia During Neonatal Circumcision

NCT04252313 | Unknown

• 1 other identifier: BIO-2018-0405
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Keywords

Music; Neonatal Circumcision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Heart Rate

  4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.

• Oxygen Saturation

  4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.

• Crying Time

  4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.

Study Arms (2)

Group A

NO INTERVENTION

This arm represents the control group. They will be undergoing the circumcision without any music, with the established standard for analgesia \[EMLA+Sucrose+Ring Block\]

Group B: Music

EXPERIMENTAL

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

Interventions

Music OTHER

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.

Group B: Music

Eligibility Criteria

• Age: 24 Hours - 48 Hours
• Gender Eligibility Details: The study is about male neonatal circumcision.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, 1107 2020, Lebanon

RECRUITING

Related Publications (3)

• 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.

  PMID: 8413140 BACKGROUND

• 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.

  PMID: 29712767 RESULT

• 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.

  PMID: 35000838 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rana Sharara-Chami, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zavi Lakissian, MD, MPH, PgD

CONTACT

009611350000; zl00@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The infant's parents signing the participation consent are blinded to the child's randomization allocation. The Surgeon performing the circumcision is wearing noise-cancelling headphones, therefore is unaware of the patient's randomization. The outcomes assessors are evaluating the videos in mute. Both surgeons and assessors are investigators on the study; only the statistician, the study coordinator and the assistant are aware of the randomization allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics and Pediatric Critical Care

Model Details: Participants are assigned to either the control group \[Only EMLA+Sucrose+Ring Block\] or the Intervention \[EMLA+Sucrose+Ring Block+ Music\]

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: August 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)