Music as Analgesia During Neonatal Circumcision

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Music Therapy for Pain Management for Minor Procedures in Neonates.

NCT04313179

Pain

TERMINATED NA

Analgesic Effect of Oral Glucose in Neonates

NCT04467177

Pain

UNKNOWN NA

The Effect of 3 Different Auditory Applications on Newborn Heel Prick Procedure

NCT06167551

Newborn Pain

NOT_YET_RECRUITING NA

Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns

NCT07081048

Newborn

RECRUITING NA

Analgesic Properties of Oral Sucrose During Immunizations

NCT00446875

Procedural Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Music

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

24 Hours

Maximum Eligible Age

48 Hours

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes