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Trial registered on ANZCTR


Registration number
ACTRN12615000271505
Ethics application status
Approved
Date submitted
11/03/2015
Date registered
23/03/2015
Date last updated
30/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing efficacy of music therapy, sucrose and combination of the two for pain relief in neonates undergoing heel prick procedure.
Scientific title
Comparing efficacy of music therapy, sucrose and combination of the two in neonates for pain relief during heel prick procedure.
Secondary ID [1] 286322 0
NIL
Universal Trial Number (UTN)
U1111-1167-9614
Trial acronym
Music therapy for Neonates
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Pain 294419 0
Condition category
Condition code
Reproductive Health and Childbirth 294729 294729 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study neonate undergoing heel prick procedure for blood collection will get in random order - Oral sucrose (Sterile 24%), Music therapy and combination of the above two methods in addition to standrad practice of swaddling and oral pacifier.

Intervention I (MT) - Music therapy

Intervention II (S) - Oral sucrose (24 %) with no music

Intervention III (MT+S) - Oral sucrose (24 %) with music therapy

MT group - In MT group the neonate will be exposed to Passive music therapy with instrumental lullabies with sounds up to 65 dB starting 20 minutes before the heel prick, continuing for 6 minutes after the painful procedure.

S group – In S group the neonates will have no music. He/she will have oral sucrose (24 % sterile solution) 0.5 ml, two minutes prior to the beginning of the heel prick as per the current hospital protocol.

MT+S group - In MT+S group the neonate will be exposed to Passive music therapy with instrumental lullabies with sounds up to 65 dB starting 20 minutes before the heel prick, continuing for 6 minutes after the painful procedure. In addition he/she will then have oral sucrose (24 % sterile solution) 0.5 ml, two minutes prior to the beginning of the heel prick as per the current hospital protocol.

This is a crossover study with each neonate getting all three interventions in random order. There will be a minimum of 40 minutes of 'wash-out' period between subsequent interventions.
Intervention code [1] 291379 0
Treatment: Other
Comparator / control treatment
Oral sucrose therapy for pain relief for heel prick in Neonates.
Control group
Active

Outcomes
Primary outcome [1] 294506 0
Is Music therapy or combination of music therapy with sucrose better for pain relief during heel prick procedure when compared with oral sucrose using PIPP score for neonates.
Timepoint [1] 294506 0
First eight minutes post heel prick procedure
Secondary outcome [1] 313482 0
Is the heart rate more stable in neonates exposed to music therapy as compared to sucrose 24 %. The heart rate will be assessed by continuous video recording of the pulse oximeter, connected to the newborn with saturation probe.
Timepoint [1] 313482 0
Every 30 second (1/2 minute) time slot assessment for seven minutes after heel prick.
Secondary outcome [2] 313641 0
Is the oxygen saturation more stable in neonates exposed to music therapy as compared to sucrose 24 %. The oxygen saturation will be assessed by continuous video recording of the pulse oximeter, connected to the newborn with saturation probe.
Timepoint [2] 313641 0
Every 30 second (1/2 minute) time slot assessment for seven minutes after heel prick.

Eligibility
Key inclusion criteria
1. Newborns >/= 32 weeks

2. Stable clinical condition with no need of CPAP/high flow/Ventilation

3. Anticipated need for repeated heel prick samples for monitoring and blood collection
Minimum age
0 Hours
Maximum age
28 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of major congenital abnormality
2. Presence of proven or suspected sepsis
3. Suspicion or confirmed NEC
4. Need of CPAP/high flow/Ventilation in last 24 hrs.
5. Major IVH, history of seizures, HIE, neonatal encephalopathy
6. Hypoglycaemia with BSL < 1.5 mmol/L

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible infants with inclusion criterion would be recruited from high dependency and special care unit of the hospital NICU.

The parents would be approached and be informed in detail about the study, inviting any questions from parents. They will be provided with parent information sheet outlining the study in detail.

Each infant will be exposed to all three therapies (Music Therapy, Oral Sucrose and combination of the two) in random sequence. Allocation concealment of the sequence of therapy will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation concealment of the sequence of therapy will be done by sealed opaque envelopes using computer generated sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3554 0
Royal North Shore Hospital
Recruitment postcode(s) [1] 9359 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 290901 0
Hospital
Name [1] 290901 0
Department of Neonatology

Royal North Shore Hospital
Address [1] 290901 0
Reserve Road, St Leonards NSW 2065
Country [1] 290901 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Department of Neonatology

Reserve Road, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 289583 0
None
Name [1] 289583 0
Nil
Address [1] 289583 0
Nil
Country [1] 289583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292504 0
North Sydney Local Health District HREC
Ethics committee address [1] 292504 0
Level 13 Kolling Building

Royal North Shore Hospital

St Leonards NSW 2065
Ethics committee country [1] 292504 0
Australia
Date submitted for ethics approval [1] 292504 0
16/03/2015
Approval date [1] 292504 0
25/05/2015
Ethics approval number [1] 292504 0

Summary
Brief summary
Does the use of Music Therapy or Combination of music therapy with sucrose (24 % sterile sugar water) provide similar or better pain relief compared to Sucrose during the heel prick procedure.

The research is aimmed to see if we can reduce the usage of sucrose, especially repeated and higher dosages in NICU with the help of music therapy which is relatively safe (within the recommened sound dose levels) and developementally appropriate intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55590 0
Dr Swapnil Shah
Address 55590 0
Department of Neonatology

Royal North Shore Hospital

Reserve Road, St Leonards NSW 2065

Country 55590 0
Australia
Phone 55590 0
+61 2 9463 2141
Fax 55590 0
+61 2 9463 2004
Email 55590 0
swapnilshah12@yahoo.co.in
Contact person for public queries
Name 55591 0
A/Prof John Sinn
Address 55591 0
Department of Neonatology

Royal North Shore Hospital

Reserve Road, St Leonards NSW 2065
Country 55591 0
Australia
Phone 55591 0
+61 2 9463 2141
Fax 55591 0
+61 2 9463 2004
Email 55591 0
john.sinn@sydney.edu.au
Contact person for scientific queries
Name 55592 0
A/Prof John Sinn
Address 55592 0
Department of Neonatology

Royal North Shore Hospital

Reserve Road, St Leonards NSW 2065
Country 55592 0
Australia
Phone 55592 0
+61 2 9463 2141
Fax 55592 0
+61 2 9463 2004
Email 55592 0
john.sinn@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary