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Clinical Trials/NCT02266199
NCT02266199CompletedNot Applicable

Validation of a New Questionnaire Regarding Pain Management in Hospitals Using a Qualitative Verification

Ruhr University of Bochum3 sites in 1 country350 target enrollmentStarted: November 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
350
Locations
3
Primary Endpoint
Interview

Study Overview

Brief Summary

The study includes operative as well as conservative patients using a questionnaire containing items of pain quality. After having completed the questionnaire, the patient is interviewed by an assistant. By this way the new questionnaire should be validated.

In addition the patient´s personal experiences are included and conservative patients can be compared to operative patients.

Detailed Description

It is validated whether the questions are formulated comprehensively and the patient consequently is able to understand all the different interrogated aspects of the questionnaire.

Exemplarily the patient is asked to express his pain in an analogue scale in various situations and which type of pain they experience (for example headache).

Moreover, it is tested whether there is a relation between the pain and the treatment he receives, and whether the patient expressed the need for additional medication.

Besides, it is asked whether he already took medication before his hospitalisation.

With help of the interview, which is conducted subsequent to the questionnaire, it is verified if the patient understands the aspects. Some of the questions are interrogated in depth by additional questions, for example which type of pain he experiences in which situation.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Signing the consent form
  • Patients with acute postoperative pain
  • Patients with acute pain with conservative treatment
  • Patients with ≥ 18 years of age

Exclusion Criteria

  • Lack of signature of the informed consent
  • All physical and mental impairments which don´t allow the completion of the questionnaire or answering the interview
  • Difficulties with the German language
  • <18 years of age
  • Isolation of patient

Outcomes

Primary Outcomes

Interview

Time Frame: 10-60 minutes

directly after answering the questionnaire, the patients are interviewed face-to-face about the personal background to answer the questions that way and does they understood the questions like the experts

Secondary Outcomes

  • Grading of pain management(10-60 minutes)
  • Pain intensity(10-60 minutes)

Investigators

Sponsor
Ruhr University of Bochum
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christoph Maier, Prof. Dr.

Prof. Dr.

Ruhr University of Bochum

Study Sites (3)

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