Clinical trial NCT01914341: Short Term Effects of Live Music in Newborn Infants
Official title: Short-term Effects of Live Pentatonic Music on Physiological Parameters in Newborns Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Infant
Keywords: Infant
Newborn
Music
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2013-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effects of live music on physiological parameters in newborn infants. The mother is asked about the effects of music on her own and the child's wellbeing.


Eligibility criteria: Inclusion Criteria:

* Gestational age ≥ 35 weeks
* signed informed consent of the parents
* positive proof of hearing ability (TEOAE, transitory evoked otoacoustic emission)
* positive 10-minute Apgar-Score \> 7

Exclusion Criteria:

* Heart defect or known cardiac arrhythmia
* other diseases of the preterm and newborn period (including infections and chromosomal aberrations)
* participation in other studies

Primary outcomes:
measure: heartrate
timeFrame: physiological parameters are measured twice over a period of 45 minutes
Secondary outcomes:
measure: Oxygen saturation
timeFrame: physiological parameters are measured twice over a period of 45 minutes.
measure: Breathing rate
timeFrame: physiological parameters are measured twice over a period of 45 minutes
measure: Apnoea > 4 sec per hour
timeFrame: physiological parameters are measured twice over a period of 45 minutes
measure: Bradycardia < 80 bpm/h
timeFrame: physiological parameters are measured twice over a period of 45 minutes
measure: Tachycardia > 200 bmp/h
timeFrame: physiological parameters are measured twice over a period of 45 minutes
measure: heart rate variability-parameters (HRV)
timeFrame: physiological parameters are measured twice over a period of 45 minutes
measure: Perfusion Index (PI)
timeFrame: physiological parameters are measured twice over a period of 45 minutes
measure: Pulse-Transit-Time (PTT)
timeFrame: physiological parameters are measured twice over a period of 45 minutes
measure: State Trait Anxiety Inventory
timeFrame: Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).
measure: State of the child
timeFrame: Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).
measure: Additional music questions
timeFrame: The additional music questions are filled in by the child's mother after the music intervention (during the15 minutes directly after the music intervention).
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Filderklinik
state: Baden-Württemberg
Study officials:
affiliation: ARCIM-Institute; University Hospital Tuebingen
name: Jan Vagedes, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. doi: 10.1111/j.0730-7659.2006.00090.x.
citation: Bo LK, Callaghan P. Soothing pain-elicited distress in Chinese neonates. Pediatrics. 2000 Apr;105(4):E49. doi: 10.1542/peds.105.4.e49.
citation: Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. doi: 10.1053/jpdn.2002.124128.