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Maternal Singing During Kangaroo Care in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01427894
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Prematurity Maternal Anxiety Other: Maternal singing with Kangaroo Care

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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.
Study Start Date : November 2011
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Reduced Heart Rate [ Time Frame: 30 minutes ]
  2. Reduced respiratory rate [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Als' Behavioral Score [ Time Frame: 1 hour ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427894


Locations
Israel
NICU
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center