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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 May 2015 |
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Main ID: |
NCT02434432 |
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Date of registration:
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20/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Music Therapy for Pain Management in the NICU Setting
MTP |
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Scientific title:
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Music Therapy as a Method of Non-Pharmacological Pain Management in the NICU Setting |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02434432 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Lebanon
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants will be included if they meet the following criteria: between 28 to 36 weeks
gestational age, stable condition, not requiring any respiratory support, in an
isolette or open crib, are at least one week post natal age and if their mothers have
listened to music while pregnant.
Exclusion Criteria:
- Infant will be excluded if they are intubated and on a ventilator or high frequency
ventilation, if they have a congenital anomaly that mainly affects hearing, such as
craniofacial anomalies; and if they have brain anomalies associated with neurological
disorders such as: grade 3-4 intraventricular hemorrhage and periventricular
leukomalacia.
Age minimum:
28 Weeks
Age maximum:
36 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Music Therapy
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Intervention(s)
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Behavioral: music therapy selected by mothers
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Behavioral: Music therapy recorded lullaby
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Primary Outcome(s)
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pain responses of preterm infants assessed on the NPASS
[Time Frame: During a heelstick procedure 5 minutes after the music conditions 1 & 2 or the control]
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Secondary Outcome(s)
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Physiologic resposnes
[Time Frame: 5 minutes before, during and five minutes after the heelstick]
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Behavioral responses
[Time Frame: Recorded at 5 minutes before during and five minutes after the heelstick]
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Secondary ID(s)
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NUR.LB.02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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