Validation of a New Questionnaire Regarding Pain Management

Completed

• Conditions: Pain

• Registration Number: NCT02266199
• Lead Sponsor: Ruhr University of Bochum

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.

One important aspect is to find out whether the patient is conscious about his medication.

In order to do so, schedules are used, which are based on the documented patient's history.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-08-22
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-12
• Last Update Submitted: 2014-10-12
• Study First Posted: 2014-10-16
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interview	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 Outcome Measures

Name	Time	Method
Grading of pain management	10-60 minutes	using a grading scale 1 (very good) - 6 (unsufficient)
Pain intensity	10-60 minutes	The pain intensity of the current pain, the exercise-related pain and the worst pain intensity in the last 24h is specified by the numerical rating scale ranging from 0-10 (NRS with 0 = no pain and 10 = worst pain imaginable)

Trial Locations

Locations (3)

Bergmannsheil, department for pain management; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany

Knappschaftskrankenhaus; 🇩🇪 Bochum Langendreer, Nordrhein-Westfalen, Germany

Marienhospital; 🇩🇪 Witten, Nordrhein-Westfalen, Germany