Trial document





This trial has been registered retrospectively.
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  DRKS00004276

Trial Description

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Title

Normal emotion regulation in adults with cleft lip and palate: An exploratory study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Emotions are complex mental processes, which consist of different components. They represent an essential part of our personality and are understood as the motivation for our actions. They play a significant role in interpersonal communication and how we are perceived by our environment. One important component is expressive behavior. We show our emotions using different facial expressions, which can be detected by a counterpart. The cleft lip and palate (CLP) is a malformation of the earliest stage of life which nowadays can be sufficiently corrected by plastic surgery. However, these patients are striking because of the appearance of their abnormal upper lip and nose.
Thus, questions arise as to how this stigma influences the ability of patients with CLP to control their emotions.
The present study aimed at examining the basic emotional mechanisms using three different test procedures. Thirty adults with cleft lip and palate were compared with a healthy control group without a facial cleft (n=30).

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Brief Summary in Scientific Language

Emotions are complex mental processes, which consist of different components. They represent an essential part of our personality and are understood as the motivation for our actions. They play a significant role in interpersonal communication and how we are perceived by our environment. One important component is expressive behavior. We show our emotions using different facial expressions, which can be detected by a counterpart. The cleft lip and palate (CLP) is a malformation of the earliest stage of life which nowadays can be sufficiently corrected by plastic surgery. However, these patients are striking because of the appearance of their abnormal upper lip and nose.
Thus, questions arise as to how this stigma influences the ability of patients with CLP to control their emotions.
The present study aimed at examining the basic emotional mechanisms using three different test procedures.

1. emotional regulation
2. emotional decoding
3. emotional encoding.

Thirty adult patients with cleft lip and palate were compared with a healthy control group without a facial cleft (n=30).

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Organizational Data

  •   DRKS00004276
  •   2012/08/09
  •   [---]*
  •   yes
  •   Approved
  •   D433/10, 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

  •   30 adult patients with cleft lip and palate.

    Part I: Emotion regulation:
    Emotion regulation was assessed using two questionnaires. The first one is the “Ambivalence over Emotional Expressiveness questionnaire G 18” (AEQ-G18), which was introduced by King and Emmons in 1990. The test measures the emotional ambivalence of the participants, which means the possibility of incongruence between feelings and their outward appearance.
    The other one is the "Emotion Regulation Questionnaire” (ERQ), which shows how the participants deal with feelings; how they recognize them and how the feelings influence their behavior or if they repress them.

    Part II: Emotion decoding:
    Emotion decoding was scaled by the “Facially Expressed Emotion Labeling Test (FEEL-test)”. It measures the capability to recognize basic emotions. The stimulus is given by showing one of the 6 basic emotions every 300 ms on a computer screen. Following this, the participant names the emotion by choosing it from a list.

    Part III: Emotion encoding:
    Emotion encoding was scaled using an olfactory test.
  •   30 adult patients without cleft lip and palate.

    Part I: Emotion regulation.
    Emotion regulation was assessed using two questionnaires. The first one is the “Ambivalence over Emotional Expressiveness questionnaire G 18” (AEQ-G18), which was introduced by King and Emmons in 1990. The test measures the emotional ambivalence of the participants, which means the possibility of incongruence between feelings and their outward appearance.
    The other one is the "Emotion Regulation Questionnaire” (ERQ), which shows how the participants deal with feelings; how they recognize them and how the feelings influence their behavior or if they repress them.

    Part II: Emotion decoding.
    Emotion decoding was scaled by the “Facially Expressed Emotion Labeling Test (FEEL-test)”. It measures the capability to recognize basic emotions. The stimulus is given by showing one of the 6 basic emotions every 300 ms on a computer screen. Following this, the participant names the emotion by choosing it from a list.

    Part III: Emotion encoding.
    Emotion encoding was scaled using an olfactory test.


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Characteristics

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

Three different questionnaires evaluate the emotional regulation, emotional perception and emotional expression. 1. Emotion regulation: Comparison of CLP patients with healthy individuals, recorded only once with the AEQ-G18-Test und dem ERQ-Test. 2. Emotion decoding: Comparison of CLP patients with healthy individuals, recorded only once with the FEEL test. 3. Emotion encoding: Comparison of CLP patients with healthy individuals, recorded only once with a oudor sample.

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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
  •   2011/11/15
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   30   Years
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Additional Inclusion Criteria

patients: unilateral and bilateral cleft lip and palate
controls: healthy individuals without cleft lip and palate

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Exclusion Criteria

acute infections, drugs or alcohol abusus, mental diseases

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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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    • Institut für Medizinische Psychologie, Universitätsklinikum Schleswig-Holstein
    • Ms.  Prof. Dr.  Wolf-Diter  Gerber 
    • Diesterwegstr. 10-12
    • 24113  Kiel
    • Germany
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    • Abteilung für Medizinische Psychologie Zentrum für Nervenheilkunde Universitätsklinikum Bonn
    • Mr.  Priv.-Doz.  Henrik  Kessler 
    • Sigmund-Freud-Straße 25
    • 53127  Bonn
    • Germany
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    • University Clinic for Psychosomatic Medicine and Psychotherapy Medical Psychology
    • Ms.  Dr.  Kerstin  Limbrecht-Ecklundt 
    • Frauensteige 6
    • 89075  Ulm
    • 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
    end of 1:1-Block address scientific-contact
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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
  •   2012/07/31
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Trial Publications, Results and other Documents

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