Trial document




drksid header

  DRKS00009601

Trial Description

start of 1:1-Block title

Title

Validation of the German version of the Childbirth Experience Questionnaire

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

The aim of the study is the validation of the German version of the Childbirth Experience Questionnaire (CEQ; Dencker et al., 2010), which assesses different aspects of first-time mothers' childbirth.

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

Brief Summary in Scientific Language

According to the guidelines by Beaton et al. (2000) the CEQ is translated to German and back translated to English. Then a vaidation study implemets the German version in a sample of women in childbed.

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

Organizational Data

  •   DRKS00009601
  •   2015/11/20
  •   [---]*
  •   yes
  •   Approved
  •   D532/15, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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

  •   O80 -  Single spontaneous delivery
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Assessment of different aspects of childbirth with the CEQ in mothers
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Translation of the Childbirth experience questionnaire (CEQ), analysis of the dimensional structure, the relibility and validity.

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

Secondary Outcome

-

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
  •   2015/11/23
  •   300
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

mothers after childbirth

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

Exclusion Criteria

complicated delivery

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Psychologie, Universität Kiel
    • Ms.  Prof.  Anya  Pedersen 
    • Olshausenstr. 62
    • 24118  Kiel
    • 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 other
    • Klinik für Gynäkologie und Geburtshilfe, UKHS
    • Mr.  Prof. Dr. med.  Nicolai  Maas 
    • Miachaelisstr. 16
    • 24105  Kiel
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinische Psychologie und PsychotherapieInstitut für PsychologieChristian-Albrechts-Universität zu Kiel
    • Ms.  Prof. Dr.  Anya  Pedersen 
    • Olshausenstr. 62
    • 24118  Kiel
    • 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
    • Klinische Psychologie und PsychotherapieInstitut für PsychologieChristian-Albrechts-Universität zu Kiel
    • Ms.  Prof. Dr.  Anya  Pedersen 
    • Olshausenstr. 62
    • 24118  Kiel
    • 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
    • Klinische Psychologie und PsychotherapieInstitut für PsychologieChristian-Albrechts-Universität zu Kiel
    • Ms.  Prof. Dr.  Anya  Pedersen 
    • Olshausenstr. 62
    • 24118  Kiel
    • 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
  •   2016/05/01
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.