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Maternal Singing During Kangaroo Care in Preterm Infants

This study is currently recruiting participants.
Verified September 2011 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01427894
First received: September 1, 2011
Last updated: February 11, 2013
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Prematurity
Maternal Anxiety
 Other: Maternal singing with Kangaroo Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Combined Effects of Maternal Singing During Skin to Skin Contact (Kangaroo Care) in Preterm Infants in the Neonatal Intensive Care Unit Environment.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Reduced Heart Rate [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Reduced respiratory rate [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Als' Behavioral Score [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maternal Singing
Maternal singing during Kangaroo Care of stable preterm infants
 Other: Maternal singing with Kangaroo Care
Maternal singing with Kangaroo Care
No Intervention: Kangaroo Care
Kangaroo Care without singing

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria clinically stable infants

  • postmenstrual age <37 weeks
  • normal hearing confirmed by measurement of distortion product otoacoustic emission (DPOAE).

Exclusion criteria

  • 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).

Maternal inclusion criteria

  • ability to hear
  • literary ability to read and answer an anxiety questionnaire

Maternal exclusion criteria

  • signs or medical history of postpartum depression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427894

Contacts
Contact: Shmuel Arnon, MD 972-9-7472225 shmuelar@clalit.org.il

Locations
Israel
NICU Recruiting
Kfar-Saba, Israel, 44281
Contact: Shmuel Arnon, MD     09-4742225     shmuelar@clalit.org.il    
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01427894     History of Changes
Other Study ID Numbers: Mc(0023)(2011)ctil
Study First Received: September 1, 2011
Last Updated: February 11, 2013
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Meir Medical Center:
Prematurity
Music
Kangaroo Care
Bonding Mother infant

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013