Validation of a New Questionnaire Regarding Pain Management

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266199
• Other study ID #: VNQI-2012
• Status: Completed
• Phase: N/A
• First received: August 22, 2013
• Last updated: October 12, 2014
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
Germany	Bergmannsheil, department for pain management	Bochum	Nordrhein-Westfalen
Germany	Knappschaftskrankenhaus	Bochum Langendreer	Nordrhein-Westfalen
Germany	Marienhospital	Witten	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interview	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	10-60 minutes	No
Secondary	Pain intensity	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)	10-60 minutes	No
Secondary	Grading of pain management	using a grading scale 1 (very good) - 6 (unsufficient)	10-60 minutes	No