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

Sponsor
Meir Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03023267
Collaborator
(none)
50
1
2
27.7
1.8

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music therapy and Kangaroo care
  • Behavioral: Kangaroo Care alone
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Open Randomized Study on the Effect of Applying Music Therapy by Therapist in the Neonatal Intensive Care Unit (NICU).
Actual Study Start Date :
Aug 28, 2017
Actual Primary Completion Date :
Oct 10, 2019
Actual Study Completion Date :
Dec 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. parasympathetic tone [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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Weeks to 18 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neonatal Intensive Care Unit Kfar-Saba Israel 44281

Sponsors and Collaborators

  • Meir Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shmuel Arnon, Senior Neonatologist, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT03023267
Other Study ID Numbers:
  • 0283-15-MMC
First Posted:
Jan 18, 2017
Last Update Posted:
Feb 25, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2020