Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005787

Trial Description

start of 1:1-Block title

Title

The effect of music therapy on the stress-level of small preterm infants

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Available data on music therapy evaluate effects of music by recording observational parameters like infant's behavior. Currently, only two small pilot studies with (2 and 5 infants enrolled) looked at the effect of music therapy on salivary cortisol levels. We designed a prospective observational study to evaluate salivary cortisol as an indicator of infant's stress level.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

To evaluate the effect of live harp music on salivary cortisol level and physiologic parameters in preterm infants born at a birthweight below 1500g. We hypothesize that live harp music will reduce infant's stress level.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005787
  •   2014/02/26
  •   [---]*
  •   yes
  •   Approved
  •   259-10, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   R45.7 -  State of emotional shock and stress, unspecified
  •   Small preterm infants
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Music therapy for 15 Minutes on three consequtive days
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome of the study is the salivary cortisol level, measured from saliva collected prior to live harp music by mass spectrometry, 25 minutes and 4 hours after pentatonic live harp exposition.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcomes are the number of bradycardia below 100/min; the frequency of desaturations below 85% (mean values 4 hrs prior and 4 hrs after music) and the measured value of the bernese pain score for newborns prior to music, immediately after music, 40 min and 4 hours after Music

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/09/21
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   24   Weeks of pregnancy
  •   34   Weeks of pregnancy
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

(1) preterm infants born at 500 -1499g birthweight; (2) On full enteral nutrition; (3) not on any analgesic or sedating drug; (4) within 48 hours prior to music exposition: no signs of infection (increased CrP), no surfactant treatment, no arterial hypotension, no need for systemic or inhaled steroids, no IVH of any grade, no blood glucose < 40 mg/dl, no blood transfusion, not on any respiratory support
(5) Written parental consent.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

(1) Small for gestational age below 3. percentile; (2) severe malformations; chromosomal aberrations, vitium cordis, (except patent ductus arteriosus or atrial septal defect (3) family history or manifest adrenal malfunction (e.g. Adreno-genital.syndrome); (4) IVH>/=°I; (5) negative hearing screen in any ear.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Neonatologie der Kinderklinik am Perinatalznetrum der LMU-München, Grosshadern
    • Mr.  PD Dr. med.  Andreas W.  Flemmer 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Neonatologie der Kinderklinik am Perinatalznetrum der LMU-München, Grosshadern
    • Mr.  PD Dr. med.  Andreas W.  Flemmer 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Neonatologie der Kinderklinik am Perinatalznetrum der LMU-München, Grosshadern
    • Mr.  PD Dr. med.  Andreas W.  Flemmer 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Neonatologie der Kinderklinik am Perinatalznetrum der LMU-München, Grosshadern
    • Mr.  PD Dr. med.  Andreas W.  Flemmer 
    • Marchioninistrasse 15
    • 81377  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/12/23
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.