Validation of the German Version of the Injustice Experience Questionnaire (GIEVA)

February 16, 2021 updated by: University of Zurich

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

Completed

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

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • DRK Schmerz-Zentrum Mainz
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Schmerzambulanz der Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum des Saarlandes
      • Zurich, Switzerland, 8032
        • University of Zurich, Center of Dental Medicine
    • Aargau
      • Baden, Aargau, Switzerland, 5404
        • ANNR Rehaclinic
    • Luzern
      • Nottwil, Luzern, Switzerland, 6207
        • Zentrum für Schmerzmedizin, Schweizer Paraplegiker-Zentrum Nottwil
    • Saint Gallen
      • St. Gallen, Saint Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen, Schmerzzentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pain patients

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

patients answered if the IEQ-items were

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

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)
10 months
Correlations between the IEQ score and the scores of the MPQ, DASS_D, TSK, PCS, PDI
Time Frame: 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.
7 months
Number of factors as the result of a factor analysis of the IEQ-items
Time Frame: 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
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

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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