Clinical trial NCT02266199: Validation of a New Questionnaire Regarding Pain Management
Official title: Validation of a New Questionnaire Regarding Pain Management in Hospitals Using a Qualitative Verification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: questionnaire
quality assurance
qualitative Verification
conservative patients
interview
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included are all conservative and postoperative patients who are inpatients on pneumology, cardiology, neurology, gastroenterology, endocrinology, Traumatology, Plastic Surgery, Cardiothoracic Surgery, Gynecology, Abdominal Surgery

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.

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

Primary outcomes:
measure: Interview
timeFrame: 10-60 minutes
Secondary outcomes:
measure: Pain intensity
timeFrame: 10-60 minutes
measure: Grading of pain management
timeFrame: 10-60 minutes
Other outcomes:
Locations:
city: Bochum Langendreer
country: Germany
facility: Knappschaftskrankenhaus
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Bergmannsheil, department for pain management
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: Marienhospital
state: Nordrhein-Westfalen
Study officials:
affiliation: Bergmannsheil Bochum
name: Christoph Maier, Prof. Dr.
role: STUDY_DIRECTOR
References: