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Validation of a New Questionnaire Regarding Pain Management

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02266199
Enrollment
350
Registered
2014-10-16
Start date
2012-11-30
Completion date
2013-09-30
Last updated
2014-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

questionnaire, quality assurance, qualitative Verification, conservative patients, interview

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.

Interventions

None listed

Sponsors

Ruhr University of Bochum
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Interview10-60 minutesdirectly 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

MeasureTime frameDescription
Pain intensity10-60 minutesThe 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 management10-60 minutesusing a grading scale 1 (very good) - 6 (unsufficient)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026