- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01908244
Short-term Effects of Live Music in Preterm Infants (MTN05)
October 22, 2013 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design
The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Baden-Württemberg
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Filderstadt, Baden-Württemberg, Germany, 70794
- Filderklinik
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Tuebingen, Baden-Württemberg, Germany, 72076
- Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Gestational age 26-34 weeks; no use of CPAP (Continous Positive Airway Pressure) or any other form of mechanical ventilation; signed informed consent of the parents
Exclusion Criteria:
- Heart defect or known cardiac arrhythmia; other diseases of the preterm and newborn period (including infections and chromosomal aberrations) which make an additional diagnostic and therapeutic intervention unacceptable; detection of deafness (TEOAE, transitory evoked otoacoustic emission)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music
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Pentatonic music
|
No Intervention: Control
No pentatonic music
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Numbers of desaturations < 90% per hour
Time Frame: physiological parameters are measured twice over a period of 2 hours and 15 minutes
|
physiological parameters are measured twice over a period of 2 hours and 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DI < 85% (Desaturations <85%/hour)
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
|
DI < 80% (Desaturations <80% per hour)
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
|
Heart rate
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
|
Oxygen saturation
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
|
Apnoea > 4 sec /h
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
|
Bradycardia < 80 bpm/h
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
|
Tachycardia > 200 bmp/h
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
|
HRV-Parameters
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
SDNN, RMSSD, pNN50, LF/HF
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
PI
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Perfusionindex
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
PTT
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
Pulse-Transit-Time (ms)
|
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
|
State Trait Anxiety Inventory
Time Frame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
|
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
|
|
State of the child
Time Frame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
|
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
|
|
additional music questions
Time Frame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
|
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
July 23, 2013
First Submitted That Met QC Criteria
July 23, 2013
First Posted (Estimate)
July 25, 2013
Study Record Updates
Last Update Posted (Estimate)
October 23, 2013
Last Update Submitted That Met QC Criteria
October 22, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARCIM_MTN05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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