Trial document




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  DRKS00003284

Trial Description

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Title

Personality, voice, and ECG of patients with autoimmune disease

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Trial Acronym

PAVE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of the study is to investigate whether patients suffering from Crohn's disease show differences from healthy control subjects with respect to their personality, their speech melody, and their heart signal. In an experimental session participants will be asked to a) fill in three questionnaires (addressing their health condition, contentment and personality), b) pronunciate 18 standardized sentences for a voice recording, and c) let their heart signal be recorded under rest condition.

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Brief Summary in Scientific Language

The purpose of the study is to investigate whether patients suffering from Crohn's disease show differences from healthy control subjects with respect to their personality, their speech prosody, and their electrocardiogram (ECG). In an experimental session participants will be asked to a) fill in three questionnaires (a health questionnaire, the IBDQ and the NEO-FFI), b) pronunciate 18 standardized sentences for a voice recording, and c) let a standart 12-lead rest ECG be recorded.

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Organizational Data

  •   DRKS00003284
  •   2011/09/28
  •   [---]*
  •   yes
  •   Approved
  •   9/2011, Berlin - Ethikkommission der Freien Universität Berlin
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K50 -  Crohn's disease [regional enteritis]
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   After patients suffering from Crohn's disease have been included in the study, they are asked to fill in a health questionnaire, which was designed by the researchers. Second, they are handed a computer-based version of the IBDQ-D (Janke et al. 2005), which measures contentment of patients with inflammatory bowel diseases. In the following the patient's voice is recorded while he/she speaks out 18 researcher-prepared sentences. A computer-based version of the personality questionnaire NEO-FFI (Borkenau & Ostendorf, 1993) is then handed to the patients. Finally a three-minute standard 12 lead ECG is recorded. After the patient has been payed, the experimental session ends.

    The experiment is completely noninvasive, there are no medicines applied and no additional risks are caused for the patient.
  •   Healthy control subjects: The entire experimental process is identical for patients and healthy controls.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

Data are analyzed after completion of the noninvasive measurement phase. The following comparisons will be made:
1. ECG amplitude parameters of patients and healthy controls will be statistically compared
2. Personality indices of patients and healthy controls as measured by the NEO-FFI will be statistically compared

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Secondary Outcome

The following additional comparisons will be made:
- Speech prosody parameters from the voice recordings of patients and healthy controls will be statistically compared

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/11/24
  •   130
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Included in the study are men and women who suffer from Crohn's disease, and healthy control subjects who do not suffer from any chronical disease.

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Exclusion Criteria

1. non-german mother tongue (because of the voice recordings)


2. Physical health problems which can interfere with the measurements:
- Blood vessel or heart diseases
- Chronic inflammatory or degenerative diseases of the CNS
- Psychiatric diseases
- Acute indisposition
- Drug addiction or alcoholism


3. Pregnancy

4. Doubts concerning contractual capability or ability to reason

5. Only control group: Any chronical disease

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Charite Campus Virchow-Klinikum
    • Mr.  Prof. Dr. med  Daniel  Baumgart 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Freie Universität Berlin, FB Erziehungswissenschaft & Psychologie, Exzellenzcluster "Languages of Emotion"
    • Mr.  Prof. Dr. rer. nat.  Stefan  Koelsch 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Freie Universität Berlin, Exzellenzcluster "Languages of Emotion"
    • Ms.  MSc  Maria  Sumpf 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.