Clinical trial NCT02552719: Validation of the German Version of the Injustice Experience Questionnaire
Official title: Validation of the German Version of the Injustice Experience Questionnaire (IEQ) in 6 Pain Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Validation Studies
Keywords: Injustice Experience
Questionnaire
Validation
German translation
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Kantonsspital Baden
name: Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
name: Cantonal Hospital of St. Gallen
name: University Hospital, Saarland
name: Swiss Paraplegic Research, Nottwil
First posted: 2015-09-17
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pain patients

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients' confirmative responses related to the 12 IEQ-items in a questionnaire concerning 1) comprehensiveness, 2) acceptance, 3) offensiveness
timeFrame: 10 months
measure: Percentage of non-confirmative responses of two raters about the patients' considerations about 1) the meaning of IEQ-items, 2) the chosen response option
timeFrame: 10 months
measure: Correlations between the IEQ score and the scores of the MPQ, DASS_D, TSK, PCS, PDI
timeFrame: 7 months
measure: Number of factors as the result of a factor analysis of the IEQ-items
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: DRK Schmerz-Zentrum Mainz
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: Schmerzambulanz der Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum des Saarlandes
state: Saarland
city: Baden
country: Switzerland
facility: ANNR Rehaclinic
state: Aargau
city: Nottwil
country: Switzerland
facility: Zentrum für Schmerzmedizin, Schweizer Paraplegiker-Zentrum Nottwil
state: Luzern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen, Schmerzzentrum
state: Saint Gallen
city: Zurich
country: Switzerland
facility: University of Zurich, Center of Dental Medicine
Study officials:
affiliation: University of Zurich
name: Dominik Ettlin, MD, DMD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Sullivan, Michael J. L., Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 1995;7(4):524-532
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.
citation: Kori S, Miller R, Todd D. Kinesiophobia: a new view of chronic pain behavior. Pain Management 1990:35-43
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.
citation: 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.
citation: 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.
citation: 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.