The Contribution of Parent-infant Interaction While Singing During Kangaroo Care, on Preterm-infants' Autonomic Stability and Parental Anxiety Reduction
Primary Purpose
PreTerm Birth, Stress Reaction
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Music therapy and Kangaroo care
Kangaroo Care alone
Sponsored by
About this trial
This is an interventional supportive care trial for PreTerm Birth
Eligibility Criteria
Inclusion criteria:
- Preterm infants ≤ 37 weeks' gestation
- Clinically stable preterm
- Hearing confirmed by distortion product oto- acoustic emissions
Exclusion criteria:
- Preterm infants treated with Central Nervous System (CNS) related medication (Luminal, Oxygen)
- Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia
- Parents refusal to participate
Sites / Locations
- Neonatal Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interventional
Control
Arm Description
Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization
Applying only Kangaroo care to mothers and fathers during their stay in the NICU
Outcomes
Primary Outcome Measures
parasympathetic tone
The electrocardiogram analogue signal from a cardiorespiratory monitor fed into a computer containing the Heart Rate Variability (HRV) software (ANSR1000 system Ansar, Inc., Philadelphia, Pennsylvania , USA). The analogue electrocardiogram signal is converted to digital values reflecting cyclic changes in the RR interval. The data is transformed into a waveform across a spectrum of various frequencies. Frequencies measured in hertz (1 Hz = 1 cycle/sec). Applied to variability, The high frequency (HF) power spectrum is in the frequency range of >0.15-1.80 Hz, which is predominately influenced by parasympathetic inputs.
Secondary Outcome Measures
Full Information
NCT ID
NCT03023267
First Posted
January 10, 2017
Last Updated
February 23, 2020
Sponsor
Meir Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03023267
Brief Title
The Contribution of Parent-infant Interaction While Singing During Kangaroo Care, on Preterm-infants' Autonomic Stability and Parental Anxiety Reduction
Official Title
Open Randomized Study on the Effect of Applying Music Therapy by Therapist in the Neonatal Intensive Care Unit (NICU).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects
Detailed Description
Premature infants and their parents are prone to high anxiety levels and a risk of experiencing trauma due to the preterm birth and its implications. Facing various emotional physical and neural high-risk factors may lead to continuous stress reactions in both the infant and parents, affecting their well being, the parent-infant relationship and the infant's medical state outcome. Attending to both infants' emotional and physiological needs of stability and comfort, as well as parents' support, can lead to an improvement in the premature infants' medical state and the parent-infant bonding process. Furthermore, reducing stress reaction facilitates perceptual memory and learning in premature infants. Two well established interventions in the neonatal care aiming to address the varied premature-family needs are Kangaroo care (KC) and Music Therapy (MT). Various research and clinical reports over the last three decades, regarding each modality, has shown beneficial effects in improvement and stabilization of infants' medical state, inclusion of parents in their infants' treatment and in facilitation of meaningful parent-infant interactions to promoting bonding patterns. However, a major lack of rigorous Randomized control studies presenting the clinical applications of MT techniques and methods in the NICU care exists, as well as only few research have positioned the parents in center of investigation, and/or presented their outcome and perspective. Accordingly, only few research have investigated the combination of MT and KC through an RCT. The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreTerm Birth, Stress Reaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Applying only Kangaroo care to mothers and fathers during their stay in the NICU
Intervention Type
Behavioral
Intervention Name(s)
Music therapy and Kangaroo care
Intervention Description
Mother holding baby in skin to skin position while singing
Intervention Type
Behavioral
Intervention Name(s)
Kangaroo Care alone
Intervention Description
Mother holding baby in skin to skin position without singing
Primary Outcome Measure Information:
Title
parasympathetic tone
Description
The electrocardiogram analogue signal from a cardiorespiratory monitor fed into a computer containing the Heart Rate Variability (HRV) software (ANSR1000 system Ansar, Inc., Philadelphia, Pennsylvania , USA). The analogue electrocardiogram signal is converted to digital values reflecting cyclic changes in the RR interval. The data is transformed into a waveform across a spectrum of various frequencies. Frequencies measured in hertz (1 Hz = 1 cycle/sec). Applied to variability, The high frequency (HF) power spectrum is in the frequency range of >0.15-1.80 Hz, which is predominately influenced by parasympathetic inputs.
Time Frame
During intervention of music and\or kangaroo care which will carry on once during 32-36 weeks gestation and once at 3 months corrected age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
18 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Preterm infants ≤ 37 weeks' gestation
Clinically stable preterm
Hearing confirmed by distortion product oto- acoustic emissions
Exclusion criteria:
Preterm infants treated with Central Nervous System (CNS) related medication (Luminal, Oxygen)
Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia
Parents refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Grause, RD
Organizational Affiliation
Meir Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Neonatal Intensive Care Unit
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32112555
Citation
Yakobson D, Arnon S, Gold C, Elefant C, Litmanovitz I, Beck BD. Music Therapy for Preterm Infants and Their Parents: A Cluster-Randomized Controlled Trial Protocol. J Music Ther. 2020 May 2;57(2):219-242. doi: 10.1093/jmt/thaa002.
Results Reference
derived
Learn more about this trial
The Contribution of Parent-infant Interaction While Singing During Kangaroo Care, on Preterm-infants' Autonomic Stability and Parental Anxiety Reduction
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