The Contribution of Parent-infant Interaction While Singing During Kangaroo Care, on Preterm-infants' Autonomic Stability and Parental Anxiety Reduction

Open Randomized Study on the Effect of Applying Music Therapy by Therapist in the Neonatal Intensive Care Unit (NICU).

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

Study Overview

• Status: Completed
• Conditions: PreTerm Birth; Stress Reaction
• Intervention / Treatment: Behavioral: Music therapy and Kangaroo care; Behavioral: Kangaroo Care alone

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar-Saba, Israel, 44281
    • Neonatal intensive care unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Preterm infants ≤ 37 weeks' gestation
2. Clinically stable preterm
3. Hearing confirmed by distortion product oto- acoustic emissions

Exclusion criteria:

1. Preterm infants treated with Central Nervous System (CNS) related medication (Luminal, Oxygen)
2. Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia
3. Parents refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization	Behavioral: Music therapy and Kangaroo care; Mother holding baby in skin to skin position while singing
Active Comparator: Control; Applying only Kangaroo care to mothers and fathers during their stay in the NICU	Behavioral: Kangaroo Care alone; Mother holding baby in skin to skin position without singing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Study Chair: Rachel Grause, RD, Meir Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Fractures, Stress
• Other Study ID Numbers: 0283-15-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No