Clinical Trials Logo
  1. Home
  2. Preterm Birth
  3. NCT03023267

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

PreTerm Birth Clinical Trial

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

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03023267
Study type Interventional
Source Meir Medical Center
Contact
Status Completed
Phase N/A
Start date August 28, 2017
Completion date December 20, 2019
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Completed NCT02993744 - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone N/A
Active, not recruiting NCT02673216 - Infection and Adverse Pregnancy Outcome
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT01412931 - Protein and Ultrasound Indicators of Preterm Birth N/A
Completed NCT02606058 - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures? N/A
Terminated NCT03715530 - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women N/A
Completed NCT00422526 - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial Phase 3
Enrolling by invitation NCT04251260 - Effectiveness of Positioning in Preterm Neonates N/A
Completed NCT03668860 - India Dexamethasone and Betamethasone Phase 1
Recruiting NCT03638037 - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed NCT02225353 - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery Phase 2
Recruiting NCT03992534 - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth Phase 1
Completed NCT03144141 - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery N/A
Completed NCT05210985 - Examination of the Relationship Between Home Affordances With Development
Completed NCT04021654 - What is the Future of Vulnerable New-borns