Trial document





This trial has been registered retrospectively.
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  DRKS00003084

Trial Description

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Title

Anxiety and need for information prior to surgery.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Preoperative anxiety may interfere with a good clinical outcome after surgery.

In this study we assess the degree of prooperative anxiety and need for information by using an economic, six-item questionnaire (Amsterdam Preoperative Anxiety and Information Scale APAIS). With this questionnaire-based survey, we assess all patients undergoing premedication visit in a fixed period.

Physicians performing the premedication visit are requested to estimate patient's anxiety and need for information by using an adapted APAIS.

We calculate realtions of anxiety and socio-demograhic variables such as age, sex, and educational background.

Psychometric properties of the APAIS will be checked as well as the quality of physician's judgement.

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Brief Summary in Scientific Language

In an unselecteted group of patientes prior to surgery we assess anxiety and need for information related to surgery and anaesthesia. While checking the psychometric properties of the APAIS, we determine effects of sociodemographic variables on anxiety and information demands. Correaltions between subjects self-report and physicians ratings are calculated.

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Organizational Data

  •   DRKS00003084
  •   2011/05/20
  •   [---]*
  •   yes
  •   Approved
  •   837.034.11(7576), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   Anxiety and need for information prior to surgical procedures.
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Interventions/Observational Groups

  •   Monitoring group: All patients prior to surgery.
    Questionnaire-based survey prior to premedication visit. Questionnaires used:
    1. Socis-demographic variables.
    2. Amsterdam Preoperative Anxiety and Information Scale APAIS
    3. Inventory State-Trait-Operation-Anxiety STOA.
    Physicians performing premedication visit are requested to rate patients anxiety and need for information by using an adapted version of the APAIS.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Degree of anxiety and need for information prior to surgery. assessement instrument: Amsterdam Preoperative Anxiety and Information Scale APAIS. Time of measurement: Prior to premedication visit.

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Secondary Outcome

1. Correlations of Amsterdam Preoperative Anxiety and Information Scale APAIS and Inventory State-Trait-Operation-Anxiety STOA.


2. Relations of sociodemographic variables and APAIS-scores by using anova.

3. Psychometric properties of the APAIS by calculating internal consistency.

4. Correlations between subjects self-report and physicians ratings.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/12/15
  •   220
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Minimum of 18 years. German language in speaking and writing. Capability of giving consent.

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Exclusion Criteria

Delirium, dementia or other mental disorders with significant cerebral dysfunction. People under guardianship.

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Addresses

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Klinik für Anästhesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  Dr. med.  Rita  Laufenberg-Feldmann 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Klinik für Anästhesiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  Dr. med.  Rita  Laufenberg-Feldmann 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/01/06
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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.