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Maternal Singing During Kangaroo Care in Preterm Infants

Primary Purpose

Prematurity, Maternal Anxiety

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Maternal singing with Kangaroo Care
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prematurity focused on measuring Prematurity, Music, Kangaroo Care, Bonding Mother infant

Eligibility Criteria

1 Week - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NICU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Maternal Singing

Kangaroo Care

Arm Description

Maternal singing during Kangaroo Care of stable preterm infants

Kangaroo Care without singing

Outcomes

Primary Outcome Measures

Reduced Heart Rate
Reduced respiratory rate

Secondary Outcome Measures

Als' Behavioral Score

Full Information

First Posted
September 1, 2011
Last Updated
March 15, 2016
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01427894
Brief Title
Maternal Singing During Kangaroo Care in Preterm Infants
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 Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Maternal singing to preterm infants during Kangaroo Care intervention, is it beneficial? Protocol Maternal voice is a predominant source of multimodal stimulation for the developing fetus that is largely lost for the preterm infant amidst the unfiltered levels of auditory stimuli in the neonatal intensive care unit (NICU). These elevated levels of auditory stimulation in the NICU can interfere with an infant's sleep and have a negative effect on vital signs and oxygen saturation. Common sources of sound for the preterm infant are derived from routine incubator noise, monitoring alarms, and the speech sounds of healthcare team, all of which they would not typically encounter if life in the uterus had continued to term. In the midst of these additional sounds, preterm infants lose significant contact with an auditory stimulus they would typically be exposed to until full-term birth (their mothers' voice). Skin to skin contact care (Kangaroo care) was found to produce cardiorespiratory stability, decrease apneic and periodic breathing, and improve sleep patterns and weight gain in preterm infants. This technique has also been shown to help mothers of preterm infants to develop and strengthen self-confidence and attachment behaviors, leading to reduced stress response. Live music was shown to have a beneficial effect on psychophysiological responses in both mothers and preterm infants during their stay in the NICU. Aim: To evaluate the combined influence of live maternal singing during kangaroo care (KC) on maternal anxiety and stable preterm infants' responses. Participants 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. Procedure A within-subject, crossover, repeated design will be used with participants acting as their own controls. Before starting the research, mothers will get a professional guidance of singing lullabies to their offspring, by a music therapist (E.G). The mothers will be sitting at the infants' bedside and the child will be placed in the kangaroo position with skin-to-skin contact with the mother. Each therapy session will start 30 minutes after feeding to get a relaxed infant and to test the intervention with no disturbances such as hunger. As recommended the infants will receive either KC alone for 30 minutes or KC combined with maternal singing for 30 minutes. According to the randomization schedule, both therapies will be performed in the afternoon after finishing the medical and nursing rounds, in alternating order 3 to 5 days apart to allow for a washout period, and included the same music. Monitor alarms will be silence and the door closed. Objective Sound Measurements Music and background sound levels will be checked 10 cm from the infant's ear with a sound analyzer and a decibel scale filter (407790 Octave Band Sound Analyzer, type 2 Integrating Sound Level Meter and Decibel-A Scale Filter, respectively; Extech Instruments, Melrose, MA, USA). Infant and Maternal Measures For accuracy, neonatal and maternal heart rates, oxygen saturation levels, and respiratory rates will be recorded continuously and documented every 2 minutes during all sessions. A 7-point scale to assess infants' behavioral state (deep sleep, light sleep, drowsy, quiet awake or alert, actively awake and aroused highly aroused, upset, or crying, and prolonged respiratory pause > 8 seconds) and a self-report questionnaire comprising 20 descriptive statements for measuring maternal anxiety symptoms (state-trait anxiety inventory [STAI] scale will be used at the beginning and the end of each intervention. Higher scores indicate greater anxiety, with a possible score of 20 to 80 points. Additional maternal measures will be age, ethnicity (Arab/Jews), education (8 years, elementary school; 8-12 years, high school; and >13 years, college/university degree), and affinity for music (a 5-point scale: 1, 2, 3, 4, and 5 hours, measuring the length of time spent a day listening to music). Data will be recorded by a single physician who will remain at the bedside throughout each session. Data will be analyzed in a blinded fashion another researcher who will be unaware of treatment allocations. Power Analysis: To achieve a power of 0.8 at α = 0.05 and one-tailed with a medium effect size of 0.610 and a medium correlation (r = 0.50) among two repeated measures using the F-test, a sample size of 30 mother-infant dyads will be needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Maternal Anxiety
Keywords
Prematurity, Music, Kangaroo Care, Bonding Mother infant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maternal Singing
Arm Type
Experimental
Arm Description
Maternal singing during Kangaroo Care of stable preterm infants
Arm Title
Kangaroo Care
Arm Type
No Intervention
Arm Description
Kangaroo Care without singing
Intervention Type
Other
Intervention Name(s)
Maternal singing with Kangaroo Care
Intervention Description
Maternal singing with Kangaroo Care
Primary Outcome Measure Information:
Title
Reduced Heart Rate
Time Frame
30 minutes
Title
Reduced respiratory rate
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Als' Behavioral Score
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
NICU
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
20882735
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
21809733
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.
Results Reference
result
PubMed Identifier
21261705
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.
Results Reference
result

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Maternal Singing During Kangaroo Care in Preterm Infants

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