Maternal Singing During Kangaroo Care in Preterm Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Meir Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Meir Medical Center Identifier:
First received: September 1, 2011
Last updated: February 11, 2013
Last verified: September 2011
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
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:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01427894

Contact: Shmuel Arnon, MD 972-9-7472225

NICU Recruiting
Kfar-Saba, Israel, 44281
Contact: Shmuel Arnon, MD    09-4742225   
Sponsors and Collaborators
Meir Medical Center
  More Information

Responsible Party: Meir Medical Center 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:
Kangaroo Care
Bonding Mother infant processed this record on February 04, 2016