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Maternal Singing During Kangaroo Care in Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01427894
First received: September 1, 2011
Last updated: March 15, 2016
Last verified: September 2011
  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
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 ]
  • Reduced respiratory rate [ Time Frame: 30 minutes ]

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

Enrollment: 30
Study Start Date: November 2011
Study Completion Date: November 2014
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   (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
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 ClinicalTrials.gov identifier: NCT01427894

Locations
Israel
NICU
Kfar-Saba, Israel, 44281
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: March 15, 2016

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on March 27, 2017