GIEVA: Validation of the German Version of the Injustice Experience Questionnaire

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT02552719
• Collaborator: Kantonsspital Baden (Other), Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen (Other), Cantonal Hospital of St. Gallen (Other), University Hospital, Saarland (Other), Swiss Paraplegic Centre Nottwil (Other)
• Enrollment: 210
• Locations: 6
• Actual Duration (Months): 42
• Patients Per Site: 35
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Validation Studies

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 Design

• Study Type: Observational
• Actual Enrollment: 210 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Validation of the German Version of the Injustice Experience Questionnaire (IEQ) in 6 Pain Centers
• Actual Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Dec 31, 2017

Outcome Measures

Primary Outcome Measures

1. Percentage of patients' confirmative responses related to the 12 IEQ-items in a questionnaire concerning 1) comprehensiveness, 2) acceptance, 3) offensiveness [10 months]

   patients answered if the IEQ-items were difficult to understand (yes/no) unacceptable (yes/no) offensive (yes/no)

2. Percentage of non-confirmative responses of two raters about the patients' considerations about 1) the meaning of IEQ-items, 2) the chosen response option [10 months]

   two raters judged if the patients' considerations about the meaning of the IEQ-items was understood (yes/no) the chosen response option was plausible (yes/no)

3. Correlations between the IEQ score and the scores of the MPQ, DASS_D, TSK, PCS, PDI [7 months]

   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.

4. Number of factors as the result of a factor analysis of the IEQ-items [7 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DRK Schmerz-Zentrum Mainz	Mainz	Rheinland-Pfalz	Germany	55131
2	Schmerzambulanz der Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum des Saarlandes	Homburg	Saarland	Germany	66421
3	ANNR Rehaclinic	Baden	Aargau	Switzerland	5404
4	Zentrum für Schmerzmedizin, Schweizer Paraplegiker-Zentrum Nottwil	Nottwil	Luzern	Switzerland	6207
5	Kantonsspital St. Gallen, Schmerzzentrum	St. Gallen	Saint Gallen	Switzerland	9007
6	University of Zurich, Center of Dental Medicine	Zurich		Switzerland	8032

Sponsors and Collaborators

• University of Zurich
• Kantonsspital Baden
• Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
• Cantonal Hospital of St. Gallen
• University Hospital, Saarland
• Swiss Paraplegic Centre Nottwil

Investigators

• Principal Investigator: Dominik Ettlin, MD, DMD, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

• Dillmann U, Nilges P, Saile H, Gerbershagen HU. [Assessing disability in chronic pain patients.]. Schmerz. 1994 Jun;8(2):100-10. German.
• Kori S, Miller R, Todd D. Kinesiophobia: a new view of chronic pain behavior. Pain Management 1990:35-43
• 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.
• 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.
• 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.
• 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 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.
• Sullivan, Michael J. L., Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 1995;7(4):524-532

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT02552719
• Other Study ID Numbers: IEQ2015; SNCTP000000442
• First Posted: Sep 17, 2015
• Last Update Posted: Feb 17, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by University of Zurich: Injustice Experience; Questionnaire; Validation; German translation

Study Results

No Results Posted as of Feb 17, 2021