AnalgesiaNCT04252313
Music as Analgesia During Neonatal Circumcision
A study testing Music in people with Analgesia, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 48 hours, men onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Aug 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 48 hours
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut, 1107 2020
Rana Sharara-Chami, MD, 009611350000 ext. 5536, rsharara@aub.edu.lb
Ahmad Zaghal, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Analgesia
- Being tested
- Music
- Keywords
- Music, Neonatal Circumcision
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Secondary outcomes (3)
Heart Rate
The infant is placed on a pulse oximeter during the circumcision to monitor his heart rate.
Measured: 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.
Measured: 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.
Measured: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Aug 2019
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sharara, American University of Beirut Medical Center
- Investigators
- Rana Sharara-Chami, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252313
- Sponsor's protocol ID
- BIO-2018-0405
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is only to be shared within the investigating team. The results will be shared in aggregate form.
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.
PubMed 8413140Sharara-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.
PubMed 29712767Sharara-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.
PubMed 35000838
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music as an Adjunct to Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04252313
- Acronym / sponsor ID
- BIO-2018-0405
- Conditions
- Analgesia
- Keywords
- Music, Neonatal Circumcision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to either the control group [Only EMLA+Sucrose+Ring Block] or the Intervention [EMLA+Sucrose+Ring Block+ Music]
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: MusicIn 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. |
Who may qualify
- Ages
- 24 to 48 hours
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicStudies 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. | Other | Group B: Music |
Primary outcome
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.
3 secondary outcomes
Heart Rate
Time frame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Oxygen Saturation
Time frame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Crying Time
Time frame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 8413140Lawrence 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.
- Results publication: PubMed 29712767Sharara-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.
- Derived from this study: PubMed 35000838Sharara-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.
- Individual participant dataSharing planned: No. The data is only to be shared within the investigating team. The results will be shared in aggregate form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana Sharara-Chami, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Analgesia, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zavi Lakissian, MD, MPH, PgD (009611350000 ext. 5521, zl00@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale (NIPS) (time frame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252313, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.