- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552719
Validation of the German Version of the Injustice Experience Questionnaire (GIEVA)
Validation of the German Version of the Injustice Experience Questionnaire (IEQ) in 6 Pain Centers
Purpose of the study is the validation of the German version of the Injustice Experience Questionnaire.
Pretest: Participants were informed about the aims of the study and fill in a consent form. They filled in a paper version of the German translation of the Injustice Experience Questionnaire. In a structured interview patients were asked if there were any items difficult to understand, unacceptable or offending them. Subsequently they had to answer questions about the content and meaning of the IEQ-items.
Validation Study: Participants were informed about the aims of the study and filled in a consent form. By e-mail they received an access link to the online survey. The questionnaires of the survey could be filled in at home. The survey could be interrupted and terminated later. About 20 minutes were needed to answer the 80 questions of the survey. All data was saved anonymously during the survey.
Study Overview
Status
Conditions
Detailed Description
Pretest: Participants were informed about the aims of the study and filled in a consent form. A paper version of the German translation of the Injustice Experience Questionnaire was completed in presence of the interviewer. The structure of the standardized interview followed the recommendations for pretesting transcultural translations of questionnaires. Patients were asked if there were any items difficult to understand, unacceptable or offending them. Subsequently they had to answer questions about the content and meaning of the IEQ-items. The interviewer asked all questions and entered the responses. All data were directly stored in a MySQL database at a Swiss commercial web-server (www.scientific-affairs.ch).
Validation Study: Participants are informed about the aims of the study and fill in a consent sheet. By e-mail they receive an access link to the online survey which can be completed at home. The survey includes the following questionnaires: Injustice Experience Questionnaire (IEQ), Depression subscale of the Depression, Anxiety and Stress Scale (DASS), Tampa Scale for Kinesiophobia (TSK), McGill Pain Questionnaire (MPQ), Pain Catastrophizing Scale (PCS), Pain Disability Index (PDI) and part concerning causes of pain of the German Pain Questionnaire (DSF). About 20 minutes is needed to answer the 80 questions of the survey. After completing the survey participant can choose if they would like to be informed about the results of the filled in questionnaires. All data is saved anonymously during the survey and stored in a MySQL database at a Swiss commercial web-server (www.scientific-affairs.ch).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Germany, 55131
- DRK Schmerz-Zentrum Mainz
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Saarland
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Homburg, Saarland, Germany, 66421
- Schmerzambulanz der Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum des Saarlandes
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Zurich, Switzerland, 8032
- University of Zurich, Center of Dental Medicine
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Aargau
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Baden, Aargau, Switzerland, 5404
- ANNR Rehaclinic
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Luzern
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Nottwil, Luzern, Switzerland, 6207
- Zentrum für Schmerzmedizin, Schweizer Paraplegiker-Zentrum Nottwil
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Saint Gallen
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St. Gallen, Saint Gallen, Switzerland, 9007
- Kantonsspital St. Gallen, Schmerzzentrum
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- pain (face, head or rest of the body)
- good competence of German language
- internet access
- being able to fill in a web-based survey
- adults
Exclusion Criteria:
- disuse / dependency on medication / drugs
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients' confirmative responses related to the 12 IEQ-items in a questionnaire concerning 1) comprehensiveness, 2) acceptance, 3) offensiveness
Time Frame: 10 months
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patients answered if the IEQ-items were
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10 months
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Percentage of non-confirmative responses of two raters about the patients' considerations about 1) the meaning of IEQ-items, 2) the chosen response option
Time Frame: 10 months
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two raters judged if the patients' considerations about
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10 months
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Correlations between the IEQ score and the scores of the MPQ, DASS_D, TSK, PCS, PDI
Time Frame: 7 months
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Correlations between the IEQ score and the scores of the MPQ, DASS_D, TSK, PCS, PDI are calculated and compared with the corresponding values English validation study.
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7 months
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Number of factors as the result of a factor analysis of the IEQ-items
Time Frame: 7 months
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Correspondence of the number of factors and the assigned items (as the result of a factor analysis) between the English and the German validation study
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7 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dominik Ettlin, MD, DMD, University of Zurich
Publications and helpful links
General Publications
- Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.
- Dillmann U, Nilges P, Saile H, Gerbershagen HU. [Assessing disability in chronic pain patients.]. Schmerz. 1994 Jun;8(2):100-10. doi: 10.1007/BF02530415. German.
- Meyer K, Sprott H, Mannion AF. Cross-cultural adaptation, reliability, and validity of the German version of the Pain Catastrophizing Scale. J Psychosom Res. 2008 May;64(5):469-78. doi: 10.1016/j.jpsychores.2007.12.004.
- Sullivan MJ, Adams H, Horan S, Maher D, Boland D, Gross R. The role of perceived injustice in the experience of chronic pain and disability: scale development and validation. J Occup Rehabil. 2008 Sep;18(3):249-61. doi: 10.1007/s10926-008-9140-5. Epub 2008 Jun 7.
- Stein C, Mendl G. The German counterpart to McGill Pain Questionnaire. Pain. 1988 Feb;32(2):251-255. doi: 10.1016/0304-3959(88)90074-7.
- Sullivan, Michael J. L., Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 1995;7(4):524-532
- Kori S, Miller R, Todd D. Kinesiophobia: a new view of chronic pain behavior. Pain Management 1990:35-43
- Nigpur K, Russu AC. Fear of movement/(re)injury in chronic pain: Preliminary validation of a German version of the Tampa Scale for Kinesiophobia. European Journal of Pain 2009(13 (Supplement 1)):S239.
- Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IEQ2015
- SNCTP000000442 (Registry Identifier: kofam)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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