Music as Analgesia During Neonatal Circumcision

American University of Beirut Medical Center

Status: Unknown

Conditions: Analgesia

Treatments: Other: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT04252313

BIO-2018-0405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 estimated patients

Sex: Male

Ages: 24 to 48 hours old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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206 participants in 2 patient groups

Group A

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Music