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

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Clalit Health Services

Status

Completed

Conditions

Stress Reaction
PreTerm Birth

Treatments

Behavioral: Kangaroo Care alone
Behavioral: Music therapy and Kangaroo care

Study type

Interventional

Funder types

Other

Identifiers

NCT03023267
0283-15-MMC

Details and patient eligibility

About

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

Full 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

Enrollment

50 patients

Sex

All

Ages

4 to 18 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Interventional
Experimental group
Description:
Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization
Treatment:
Behavioral: Music therapy and Kangaroo care
Control
Active Comparator group
Description:
Applying only Kangaroo care to mothers and fathers during their stay in the NICU
Treatment:
Behavioral: Kangaroo Care alone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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