NCT02552719

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

August 28, 2015

Last Update Submit

February 16, 2021

Conditions

Keywords

Injustice ExperienceQuestionnaireValidationGerman translation

Outcome Measures

Primary Outcomes (4)

  • 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)

    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

    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

    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

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pain patients

You may qualify if:

  • 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

You may not qualify if:

  • disuse / dependency on medication / drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

DRK Schmerz-Zentrum Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

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

Homburg, Saarland, 66421, Germany

Location

ANNR Rehaclinic

Baden, Canton of Aargau, 5404, Switzerland

Location

Zentrum für Schmerzmedizin, Schweizer Paraplegiker-Zentrum Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Kantonsspital St. Gallen, Schmerzzentrum

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

University of Zurich, Center of Dental Medicine

Zurich, 8032, Switzerland

Location

Related Publications (9)

  • 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.

    PMID: 18536983BACKGROUND
  • 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.

    PMID: 3362561BACKGROUND
  • Sullivan, Michael J. L., Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 1995;7(4):524-532

    BACKGROUND
  • 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.

    PMID: 18440399BACKGROUND
  • Kori S, Miller R, Todd D. Kinesiophobia: a new view of chronic pain behavior. Pain Management 1990:35-43

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 6240632BACKGROUND
  • 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.

    PMID: 18415443BACKGROUND
  • 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.

    PMID: 1235985BACKGROUND

Study Officials

  • Dominik Ettlin, MD, DMD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 17, 2015

Study Start

July 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2017

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations