Validation of the German Version of the Injustice Experience Questionnaire

Validation Studies Clinical Trial

— GIEVA  

Official title:

Validation of the German Version of the Injustice Experience Questionnaire (IEQ) in 6 Pain Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552719
• Other study ID #: IEQ2015
• Secondary ID: SNCTP000000442
• Status: Completed
• Start date: July 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Validation Studies

Locations

Country	Name	City	State
Germany	Schmerzambulanz der Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum des Saarlandes	Homburg	Saarland
Germany	DRK Schmerz-Zentrum Mainz	Mainz	Rheinland-Pfalz
Switzerland	ANNR Rehaclinic	Baden	Aargau
Switzerland	Zentrum für Schmerzmedizin, Schweizer Paraplegiker-Zentrum Nottwil	Nottwil	Luzern
Switzerland	Kantonsspital St. Gallen, Schmerzzentrum	St. Gallen	Saint Gallen
Switzerland	University of Zurich, Center of Dental Medicine	Zurich

Sponsors (6)

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

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (9)

Dillmann U, Nilges P, Saile H, Gerbershagen HU. [Assessing disability in chronic pain patients.]. Schmerz. 1994 Jun;8(2):100-10. German. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sullivan, Michael J. L., Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 1995;7(4):524-532

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients' confirmative responses related to the 12 IEQ-items in a questionnaire concerning 1) comprehensiveness, 2) acceptance, 3) offensiveness	patients answered if the IEQ-items were; difficult to understand (yes/no); unacceptable (yes/no); offensive (yes/no)	10 months
Primary	Percentage of non-confirmative responses of two raters about the patients' considerations about 1) the meaning of IEQ-items, 2) the chosen response option	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)	10 months
Primary	Correlations between the IEQ score and the scores of the MPQ, DASS_D, TSK, PCS, PDI	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.	7 months
Primary	Number of factors as the result of a factor analysis of the IEQ-items	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	7 months