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Validation StudiesGIEVANCT02552719

Validation of the German Version of the Injustice Experience Questionnaire

An observational study of Validation Studies, run by University of Zurich at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Validation Studies
How many people
210 participants
Where
6 sitesin 2 countries
Study dates
1 Jul 2014to 31 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: pain patients

Who may be able to join

  • 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

Who cannot join

  • disuse / dependency on medication / drugs

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Switzerland4 sites

  • ANNR Rehaclinic

    Baden, Canton of Aargau, 5404

  • Zentrum für Schmerzmedizin, Schweizer Paraplegiker-Zentrum Nottwil

    Nottwil, Canton of Lucerne, 6207

  • Kantonsspital St. Gallen, Schmerzzentrum

    Sankt Gallen, Canton of St. Gallen, 9007

  • University of Zurich, Center of Dental Medicine

    Zurich, 8032

Other trials in Switzerland

Germany2 sites

  • Schmerzambulanz der Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66421

  • DRK Schmerz-Zentrum Mainz

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

About this study

Official title: 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.

Read the 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).

Keywords
Injustice Experience, Questionnaire, Validation, German translation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    1. difficult to understand (yes/no)
    2. unacceptable (yes/no)
    3. offensive (yes/no)

    Measured: 10 months

  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

    two raters judged if the patients' considerations about

    1. the meaning of the IEQ-items was understood (yes/no)
    2. the chosen response option was plausible (yes/no)

    Measured: 10 months

  3. 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.

    Measured: 7 months

  4. 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

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2015 (estimated)
  2. Study start1 Jul 2014
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02552719
Sponsor's protocol ID
IEQ2015
Other IDs
SNCTP000000442
Acronym
GIEVA
Status last verified
Feb 2021
First submitted
28 Aug 2015
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18536983

  • 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.

    PubMed 3362561

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

  • 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.

    PubMed 18440399

  • 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.

    PubMed 6240632

  • 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.

    PubMed 18415443

  • 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.

    PubMed 1235985

Questions about this trial

What is this clinical trial studying?

An observational study of Validation Studies, run by University of Zurich at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02552719, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.

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