Trial document





This trial has been registered retrospectively.
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  DRKS00004281

Trial Description

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Title

Children with cleft lip and palate:
An explorative study on the role of parent-child interaction

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The interaction is per definitionem a subsequent treatment of two or more persons, respectively an interaction between partners in action. Without interaction there is no communication and without communication there will be no socialization. However, communication is no standardized process, but rather varying from human to human and depending on particular life situations, e.g. diseases.
Thus, question arise about the interactive behaviour in children with cleft lip and palate. Children with cleft lip and palate have no chronic disease like migraine or asthma, but they have to survive several operations and medical treatments.

It can be assumed that this long-lasting burden over years may cause tensions within the family. The present study aimed to examine parent-child interaction in affected families. The comparison group were represented by families with healthy children and families with children suffering by migraine.

1. Investigation of parent-child-interaction by the use of a puzzle.
2. Two questionnaires should illuminate the intrafamiliar situation.

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Brief Summary in Scientific Language

The interaction is per definitionem a subsequent treatment of two or more persons, respectively an interaction between partners in action. Without interaction there is no communication and without communication there will be no socialization. However, communication is no standardized process, but rather varying from human to human and depending on particular life situations, e.g. diseases.
Thus, question arise about the interactive behaviour in children with cleft lip and palate. Children with cleft lip and palate have no chronic disease like migraine or asthma, but they have to survive several operations and medical treatments.

It can be assumed that this long-lasting burden over years may cause tensions within the family. The present study aimed to examine parent-child interaction in affected families. The comparison group were represented by families with healthy children and families with children suffering by migraine.

1. Investigation of parent-child-interaction by the use of a puzzle.
2. Two questionnaires should illuminate the intrafamiliar situation.
The children have to fill two different questionnaires. Firstly, the „anxiety questionnaire (KAT II)“ and a questionnaire for the “assessment of health related quality of life of the children (KINDL)“.

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Organizational Data

  •   DRKS00004281
  •   2012/08/10
  •   [---]*
  •   yes
  •   Approved
  •   D 433/10, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   Q35-Q37 -  Cleft lip and cleft palate
  •   F43 -  Reaction to severe stress, and adjustment disorders
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Interventions/Observational Groups

  •   15 families composed of father, mother and affected child are included in the study. The children are aged between 7 and 10 years. Furthermore, the cleft lip and palate must not be associated with further syndroms.
    1. Examination of parent-child interaction with the help of a puzzle.
    2.Two different questionnaires which should illuminate the intrafamiliar situation.
  •   control: Children with migraine and healthy children from a previous study of Siniatchkin et al., 2003.

    Siniatchkin M, Kirsch E, Arslan S, Stegemann S, Gerber WD, Stephani U (2003) Migraine and asthma in childhood: evidence for specific asymmetric parent-child interactions in migraine and asthma families. Cephalalgia 23 (8): 790-802
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

1. Investigation of interactive behaviour with a puzzle. The parents have to solve a puzzle with the child. This situation was filmed with two different cameras and analyzed by specially trained professionals. 2. Evaluation of intrafamiliar situation with KAT II and KINDL, which was performed once.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/11/11
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   7   Years
  •   10   Years
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Additional Inclusion Criteria

Patients: Children with cleft lip and palate and their parents.
Control group: Children with migraine and healthy children and their parents from pre-study.

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Exclusion Criteria

acute infection, drugs- and alcohol abusus, mental disorder

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Addresses

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    • Klinik für Mund-, Kiefer- und Gesichtschirurgie, Universitätsklinikum Schleswig-Holstein
    • Mr.  Priv.-Doz. Dr. Dr.  Volker  Gaßling 
    • Arnold-Heller Str. 3, Haus 26
    • 24105  Kiel
    • Germany
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    • Klinik für Kinder und Jugendpsychiatrie, Johann Wolfgang Goethe-Universität, Frankfurt, Germany
    • Mr.  Prof.  Michael  Siniatchkin 
    • Deutschordenstr. 50
    • 60528  Frankfurt am Main
    • Germany
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    • Klinik für Mund-, Kiefer- und Gesichtschirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Priv.-Doz. Dr. Dr.  Volker  Gaßling 
    • Arnold-Heller Str. 3, Haus 26
    • 24105  Kiel
    • Germany
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    • Klinik für Mund-, Kiefer- und Gesichtschirurgie, Universitätsklinikum Schleswig-Holstein
    • Mr.  Priv.-Doz. Dr. Dr.  Volker  Gaßling 
    • Arnold-Heller Str. 3, Haus 26
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Mund-, Kiefer- und Gesichtschirurgie, Universitätsklinikum Schleswig-Holstein
    • Mr.  Priv.-Doz. Dr. Dr.  Volker  Gaßling 
    • Arnold-Heller Str. 3, Haus 26
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/07/05
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Trial Publications, Results and other Documents

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