NCT01914341

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

July 29, 2013

Last Update Submit

January 22, 2014

Conditions

Newborn Infant

Keywords

InfantNewbornMusic

Outcome Measures

Primary Outcomes (1)

  • heartrate

    physiological parameters are measured twice over a period of 45 minutes

Secondary Outcomes (11)

  • Oxygen saturation

    physiological parameters are measured twice over a period of 45 minutes.

  • Breathing rate

    physiological parameters are measured twice over a period of 45 minutes

  • Apnoea > 4 sec per hour

    physiological parameters are measured twice over a period of 45 minutes

  • Bradycardia < 80 bpm/h

    physiological parameters are measured twice over a period of 45 minutes

  • Tachycardia > 200 bmp/h

    physiological parameters are measured twice over a period of 45 minutes

  • +6 more secondary outcomes

Study Arms (2)

Music

EXPERIMENTAL

pentatonic live music

Other: Music

control

NO INTERVENTION

no intervention

Interventions

MusicOTHER

Live music played on the pentatonically tuned children's harp

Music

Eligibility Criteria

Age35 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Related Publications (3)

  • 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.

    PMID: 16732778BACKGROUND

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

    PMID: 10742370BACKGROUND

  • 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.

    PMID: 12029604BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jan Vagedes, Dr.

    ARCIM-Institute; University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 2, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

DE(1)