Short Term Effects of Live Music in Newborn Infants

NCT ID: NCT01914341

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Newborn Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music

pentatonic live music

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Live music played on the pentatonically tuned children's harp

control

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

Live music played on the pentatonically tuned children's harp

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Vagedes, Dr.

Role: PRINCIPAL_INVESTIGATOR

ARCIM-Institute; University Hospital Tuebingen

Locations

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Filderklinik

Filderstadt, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 16732778 (View on PubMed)

Bo LK, Callaghan P. Soothing pain-elicited distress in Chinese neonates. Pediatrics. 2000 Apr;105(4):E49. doi: 10.1542/peds.105.4.e49.

Reference Type BACKGROUND
PMID: 10742370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12029604 (View on PubMed)

Other Identifiers

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ARCIM_MTN04

Identifier Type: -

Identifier Source: org_study_id

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