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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01427894
Other study ID # Mc(0023)(2011)ctil
Secondary ID
Status Completed
Phase N/A
First received September 1, 2011
Last updated March 15, 2016
Start date November 2011
Est. completion date November 2014

Study information

Verified date September 2011
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Maternal singing with Kangaroo Care
Maternal singing with Kangaroo Care

Locations

Country Name City State
Israel NICU Kfar-Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Olischar 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. — View Citation

Schlez 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reduced Heart Rate 30 minutes No
Primary Reduced respiratory rate 30 minutes No
Secondary Als' Behavioral Score 1 hour No
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