Validation of a New Questionnaire Regarding Pain Management

NCT ID: NCT02266199

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-09-30

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.

Conditions

Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

conservative patients

in-patients on pneumology, cardiology, neurology, gastroenterology, endocrinology

No interventions assigned to this group

operative patients

inpatient on Traumatology, Plastic Surgery, Cardiothoracic Surgery, Gynecology, Abdominal Surgery

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Christoph Maier, Prof. Dr.

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Maier, Prof. Dr.

Role: STUDY_DIRECTOR

Bergmannsheil Bochum

Locations

Bergmannsheil, department for pain management

Bochum, North Rhine-Westphalia, Germany

Knappschaftskrankenhaus

Langendreer, North Rhine-Westphalia, Germany

Marienhospital

Witten, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

VNQI-2012

Identifier Type: -

Identifier Source: org_study_id