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Completed

NCT Number: NCT02552719

Validation of the German Version of the Injustice Experience Questionnaire

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.

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Key information

Conditions

Validation Studies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DRK Schmerz-Zentrum Mainz, Mainz, Rhineland-Palatinate, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    • 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

    Time frame: 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

    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.

  4. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

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

Registry information

Official study title

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

Acronym: GIEVA

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 17, 2015
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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