Maternal Singing During Kangaroo Care in Preterm Infants
The Combined Effects of Maternal Singing During Skin to Skin Contact (Kangaroo Care) in Preterm Infants in the Neonatal Intensive Care Unit Environment.
1 other identifier
interventional
30
1 country
1
Brief Summary
Study objective is to evaluate the additive effect of maternal singing during skin to skin contact (Kangaroo Care) on anxiety reduction both to infants and their mothers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 2, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMarch 16, 2016
September 1, 2011
3 years
September 1, 2011
March 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduced Heart Rate
30 minutes
Reduced respiratory rate
30 minutes
Secondary Outcomes (1)
Als' Behavioral Score
1 hour
Study Arms (2)
Maternal Singing
EXPERIMENTALMaternal singing during Kangaroo Care of stable preterm infants
Kangaroo Care
NO INTERVENTIONKangaroo Care without singing
Interventions
Eligibility Criteria
You may qualify if:
- postmenstrual age \<37 weeks
- normal hearing confirmed by measurement of distortion product otoacoustic emission (DPOAE).
You may not qualify if:
- observed hyperresponsiveness to live music
- congenital anomaly that mainly affects hearing
- medication intake (phenobarbital, furosemide, gentamycin) that might interfere with the reaction to musical stimuli
- brain anomalies associated with neurological disorders (grade 3-4 intraventricular hemorrhage, periventricular leukomalacia).
- ability to hear
- literary ability to read and answer an anxiety questionnaire
- signs or medical history of postpartum depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NICU
Kfar Saba, 44281, Israel
Related Publications (3)
Hodges AL, Wilson LL. Effects of music therapy on preterm infants in the neonatal intensive care unit. Altern Ther Health Med. 2010 Sep-Oct;16(5):72-3. No abstract available.
PMID: 20882735BACKGROUNDSchlez A, Litmanovitz I, Bauer S, Dolfin T, Regev R, Arnon S. Combining kangaroo care and live harp music therapy in the neonatal intensive care unit setting. Isr Med Assoc J. 2011 Jun;13(6):354-8.
PMID: 21809733RESULTOlischar M, Shoemark H, Holton T, Weninger M, Hunt RW. The influence of music on aEEG activity in neurologically healthy newborns >/=32 weeks' gestational age. Acta Paediatr. 2011 May;100(5):670-5. doi: 10.1111/j.1651-2227.2011.02171.x. Epub 2011 Mar 1.
PMID: 21261705RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 2, 2011
Study Start
November 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
March 16, 2016
Record last verified: 2011-09