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Trial record 2 of 2 for:    12029604 [PUBMED-IDS]

Short Term Effects of Live Music in Newborn Infants

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ClinicalTrials.gov Identifier: NCT01914341
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : January 23, 2014
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
ARCIM Institute Academic Research in Complementary and Integrative Medicine

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.

Condition or disease Intervention/treatment Phase
Newborn Infant Other: Music Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Short-term Effects of Live Pentatonic Music on Physiological Parameters in Newborns Infants
Study Start Date : July 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: Music
pentatonic live music
Other: Music
Live music played on the pentatonically tuned children's harp
No Intervention: control
no intervention



Primary Outcome Measures :
  1. heartrate [ Time Frame: physiological parameters are measured twice over a period of 45 minutes ]

Secondary Outcome Measures :
  1. Oxygen saturation [ Time Frame: physiological parameters are measured twice over a period of 45 minutes. ]
  2. Breathing rate [ Time Frame: physiological parameters are measured twice over a period of 45 minutes ]
  3. Apnoea > 4 sec per hour [ Time Frame: physiological parameters are measured twice over a period of 45 minutes ]
  4. Bradycardia < 80 bpm/h [ Time Frame: physiological parameters are measured twice over a period of 45 minutes ]
  5. Tachycardia > 200 bmp/h [ Time Frame: physiological parameters are measured twice over a period of 45 minutes ]
  6. heart rate variability-parameters (HRV) [ Time Frame: physiological parameters are measured twice over a period of 45 minutes ]
    RMSS (root mean square of successive differences) SDNN (standard deviation of normal to normal intervals) pNN50 (the proportion of NN50 (the number of pairs of successive NNs that differ by more than 50 ms) divided by total number of NNs) LF/HF (low frequency/high frequency)

  7. Perfusion Index (PI) [ Time Frame: physiological parameters are measured twice over a period of 45 minutes ]
  8. Pulse-Transit-Time (PTT) [ Time Frame: physiological parameters are measured twice over a period of 45 minutes ]
  9. State Trait Anxiety Inventory [ Time Frame: 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). ]
  10. State of the child [ Time Frame: 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). ]
  11. Additional music questions [ Time Frame: The additional music questions are filled in by the child's mother after the music intervention (during the15 minutes directly after the music intervention). ]


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Ages Eligible for Study:   35 Weeks and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914341


Locations
Germany
Filderklinik
Filderstadt, Baden-Württemberg, Germany, 70794
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
University Hospital Tuebingen
Investigators
Principal Investigator: Jan Vagedes, Dr. ARCIM-Institute; University Hospital Tuebingen

Publications:
Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT01914341     History of Changes
Other Study ID Numbers: ARCIM_MTN04
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
Infant
Newborn
Music