Validation of a New Questionnaire Regarding Pain Management

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bergmannsheil, department for pain management, Bochum, North Rhine-Westphalia, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Pain intensity

Time frame: 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)
Grading of pain management

Time frame: 10-60 minutes

using a grading scale 1 (very good) - 6 (unsufficient)

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Oct 16, 2014
Registry last updated: Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed