Validation of a New Questionnaire Regarding Pain Management

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

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.

Study Overview

• Status: Completed
• Conditions: Pain

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 Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44789
      • Bergmannsheil, department for pain management
    • Bochum Langendreer, Nordrhein-Westfalen, Germany, 44892
      • Knappschaftskrankenhaus
    • Witten, Nordrhein-Westfalen, Germany, 58452
      • Marienhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
conservative patients; in-patients on pneumology, cardiology, neurology, gastroenterology, endocrinology
operative patients; inpatient on Traumatology, Plastic Surgery, Cardiothoracic Surgery, Gynecology, Abdominal Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Grading of pain management	using a grading scale 1 (very good) - 6 (unsufficient)	10-60 minutes

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Study Director: Christoph Maier, Prof. Dr., Bergmannsheil Bochum

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: August 22, 2013
• First Submitted That Met QC Criteria: October 12, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 12, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: questionnaire; quality assurance; interview; qualitative Verification; conservative patients
• Other Study ID Numbers: VNQI-2012