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Music as Analgesia During Neonatal Circumcision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252313
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Rana Sharara, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Analgesia Other: Music Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to either the control group [Only EMLA+Sucrose+Ring Block] or the Intervention [EMLA+Sucrose+Ring Block+ Music]
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Music as an Adjunct to Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Neonatal Infant Pain Scale (NIPS) [ Time Frame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision. ]
    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.


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision. ]
    The infant is placed on a pulse oximeter during the circumcision to monitor his heart rate.

  2. Oxygen Saturation [ Time Frame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision. ]
    The infant is placed on a pulse oximeter during the circumcision to monitor his oxygen saturation.

  3. Crying Time [ Time Frame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision. ]
    The assistant will be timing the infant's crying during the circumcision, as an indicator of pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study is about male neonatal circumcision.
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252313


Contacts
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Contact: Zavi Lakissian, MD, MPH, PgD 009611350000 ext 5521 zl00@aub.edu.lb

Locations
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Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon, 1107 2020
Contact: Rana Sharara-Chami, MD    009611350000 ext 5536    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: Lama Charafeddine, MD         
Sub-Investigator: Zavi Lakissian, MD, MPH, PgD         
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Rana Sharara-Chami, MD American University of Beirut Medical Center
Publications of Results:
Other Publications:
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Responsible Party: Rana Sharara, Associate Professor of Clinical Pediatrics and Pediatric Critical Care, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT04252313    
Other Study ID Numbers: BIO-2018-0405
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data is only to be shared within the investigating team. The results will be shared in aggregate form.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rana Sharara, American University of Beirut Medical Center:
Music
Neonatal Circumcision
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases