PainNCT04313179
Music Therapy for Pain Management for Minor Procedures in Neonates.
A study testing Music therapy and Sucrose in people with Pain, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial summary
The aim of this study is to assess the effectiveness and safety of music therapy as adjuvant therapy for pain management in newborns undergoing minor painful procedures. It is a prospective study and we plan to enroll 200 healthy full term newborns undergoing minor procedures (heel pricks). Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Music therapy and Sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 25 Feb 2020
- 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 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- >37 weeks gestation babies
Who cannot join
- <37 weeks gestation babies
- Major congenital anomalies
- Failed hearing screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy as an Adjuvant Therapy for Pain Management During Heel Prick Procedures in Term Neonates.
The aim of this study is to assess the effectiveness and safety of music therapy as adjuvant therapy for pain management in newborns undergoing minor painful procedures. It is a prospective study and we plan to enroll 200 healthy full term newborns undergoing minor procedures (heel pricks). They will be randomly assigned to either control or music group. Those in music group will receive recorded Mozart lullaby music. Pain will be assessed using NIPS (Neonatal Infant Pain Scale) scoring tool. The potential benefit of the study would be identifying music a safe and efficient adjuvant therapy for pain management in newborns.
Read the detailed description
This randomized, controlled, double blinded, clinical trial will include full term neonates undergoing painful minor procedures (heel pricks) in the Nursery unit of Lincoln Medical and Mental Health Center.
One of the investigators involved in the study will obtain consent from the legal guardian and enroll the participants. All infants, regardless of the group that they are assigned, will receive similar standard non-pharmacologic method of pain relief which is 0.5 ml of 24% Sucrose, 2 minutes before undergoing heel prick. Pacifiers will be avoided to avoid potential confounding.
Subjects will be randomized into two different groups. Group A, music intervention group and group B, control group. In the music intervention group, a recorded instrumental lullaby music track called "Deep Sleep" from "Bedtime Mozart: Classical Lullabies for Babies", will be played for the neonates through smart phone speakers (maximum sound up to 60 A dB), starting 20 minutes before the heel prick, continuing through the procedure and for 5 minutes after the procedure. This music track has been selected based on previous research studies that showed effectiveness in neonatal pain management.
An investigator involved in the study will place the baby in a bassinet in a quite, dim lighted room. He/She will play the music for those babies in the music group and will NOT assess the NIPS. Another investigator wearing active noise cancelling Bluetooth headphones (for blinding) will enter the room at 5 minutes prior to the procedure and assess the NIPS at appropriate intervals: 5 minutes prior and at 1-minute interval during and after the procedure for 5 minutes. NIPS will be compared using appropriate statistical methods.
- Conditions
- Pain
- Being tested
- Music therapy, Sucrose
- Keywords
- Neonatal pain, Music therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Mozart lullaby music
SucroseOther
0.5 ml of 24% Sucrose
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | "Deep Sleep" music track from "Bedtime Mozart: Classical Lullabies for Babies", played through smart phone speakers, at maximum sound up to 45 dB, starting 20 minutes before the heel prick procedure, continuing through the procedure and for 5 minutes after the procedure. Also given 0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure for baseline pain relief. Receives: Other: Music therapy; Other: Sucrose |
| Placebo group | Placebo comparator | 0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure. No music played. Receives: Other: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in NIPS scoring by 20%
A score greater than 3 indicates pain, maximum score is 7 and minimum is 0
Measured: 5 minutes post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start9 Apr 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: COVID-19 pandemic prevented further enrollment. Interim analysis showed adequate power achieved.
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 PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pratiba Ankola, New York City Health and Hospitals Corporation
- Investigators
- Prathiba Ankola, MD, Principal investigator, Lincoln Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313179
- Sponsor's protocol ID
- IRB#18-026
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Standley J. Music therapy research in the NICU: an updated meta-analysis. Neonatal Netw. 2012 Sep-Oct;31(5):311-6. doi: 10.1891/0730-0832.31.5.311.
PubMed 22908052Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
PubMed 27561729Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, Nimbalkar S. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2018 Apr 15;55(4):292-296. Epub 2018 Feb 9.
PubMed 29428919
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy as an Adjuvant Therapy for Pain Management During Heel Prick Procedures in Term Neonates.
- ClinicalTrials.gov ID
- NCT04313179
- Acronym / sponsor ID
- IRB#18-026
- Conditions
- Pain
- Keywords
- Neonatal pain, Music therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic prevented further enrollment. Interim analysis showed adequate power achieved.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 18 Mar 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.
The aim of this study is to assess the effectiveness and safety of music therapy as adjuvant therapy for pain management in newborns undergoing minor painful procedures. It is a prospective study and we plan to enroll 200 healthy full term newborns undergoing minor procedures (heel pricks). They will be randomly assigned to either control or music group. Those in music group will receive recorded Mozart lullaby music. Pain will be assessed using NIPS (Neonatal Infant Pain Scale) scoring tool. The potential benefit of the study would be identifying music a safe and efficient adjuvant therapy for pain management in newborns.
Detailed description
This randomized, controlled, double blinded, clinical trial will include full term neonates undergoing painful minor procedures (heel pricks) in the Nursery unit of Lincoln Medical and Mental Health Center.
One of the investigators involved in the study will obtain consent from the legal guardian and enroll the participants. All infants, regardless of the group that they are assigned, will receive similar standard non-pharmacologic method of pain relief which is 0.5 ml of 24% Sucrose, 2 minutes before undergoing heel prick. Pacifiers will be avoided to avoid potential confounding.
Subjects will be randomized into two different groups. Group A, music intervention group and group B, control group. In the music intervention group, a recorded instrumental lullaby music track called "Deep Sleep" from "Bedtime Mozart: Classical Lullabies for Babies", will be played for the neonates through smart phone speakers (maximum sound up to 60 A dB), starting 20 minutes before the heel prick, continuing through the procedure and for 5 minutes after the procedure. This music track has been selected based on previous research studies that showed effectiveness in neonatal pain management.
An investigator involved in the study will place the baby in a bassinet in a quite, dim lighted room. He/She will play the music for those babies in the music group and will NOT assess the NIPS. Another investigator wearing active noise cancelling Bluetooth headphones (for blinding) will enter the room at 5 minutes prior to the procedure and assess the NIPS at appropriate intervals: 5 minutes prior and at 1-minute interval during and after the procedure for 5 minutes. NIPS will be compared using appropriate statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: Music therapy, Other: Sucrose"Deep Sleep" music track from "Bedtime Mozart: Classical Lullabies for Babies", played through smart phone speakers, at maximum sound up to 45 dB, starting 20 minutes before the heel prick procedure, continuing through the procedure and for 5 minutes after the procedure. Also given 0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure for baseline pain relief. |
| Placebo group | Placebo comparator | Other: Sucrose0.5 ml of 24% Sucrose given 2 minutes prior to heel prick procedure. No music played. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- >37 weeks gestation babies
Key exclusion criteria (3 listed)
- <37 weeks gestation babies
- Major congenital anomalies
- Failed hearing screen
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 |
|---|---|---|
| Music therapyMozart lullaby music | Other | Music group |
| Sucrose0.5 ml of 24% Sucrose | Other | Music group, Placebo group |
Primary outcome
Reduction in NIPS scoring by 20%
Time frame: 5 minutes post procedure
A score greater than 3 indicates pain, maximum score is 7 and minimum is 0
Results and safety
The study was stopped early (reason given: COVID-19 pandemic prevented further enrollment. Interim analysis showed adequate power achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Background: PubMed 22908052Standley J. Music therapy research in the NICU: an updated meta-analysis. Neonatal Netw. 2012 Sep-Oct;31(5):311-6. doi: 10.1891/0730-0832.31.5.311.
- Background: PubMed 27561729Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
- Background: PubMed 29428919Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, Nimbalkar S. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2018 Apr 15;55(4):292-296. Epub 2018 Feb 9.
- Individual participant dataSharing planned: Undecided
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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.
Prathiba Ankola, MD principal investigator
Lincoln 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 therapy and Sucrose in people with Pain, run by New York City Health and Hospitals Corporation at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 16 Mar 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: COVID-19 pandemic prevented further enrollment. Interim analysis showed adequate power achieved.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in NIPS scoring by 20% (time frame: 5 minutes post procedure). 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 NCT04313179, 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 16 Mar 2021.