PainNCT02266199
Validation of a New Questionnaire Regarding Pain Management
An observational study of Pain, run by Ruhr University of Bochum at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 350 participants
- Where
- 3 sitesGermany
- Study dates
- Nov 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Signing the consent form
- Patients with acute postoperative pain
- Patients with acute pain with conservative treatment
- Patients with ≥ 18 years of age
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Bergmannsheil, department for pain management
Bochum, North Rhine-Westphalia, 44789
Knappschaftskrankenhaus
Langendreer, North Rhine-Westphalia, 44892
Marienhospital
Witten, North Rhine-Westphalia, 58452
About this study
Official title: 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.
Read the 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
- Keywords
- questionnaire, quality assurance, qualitative Verification, conservative patients, interview
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| conservative patients | in-patients on pneumology, cardiology, neurology, gastroenterology, endocrinology | |
| operative patients | inpatient on Traumatology, Plastic Surgery, Cardiothoracic Surgery, Gynecology, Abdominal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10-60 minutes
Secondary outcomes (2)
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)
Measured: 10-60 minutes
Grading of pain management
using a grading scale 1 (very good) - 6 (unsufficient)
Measured: 10-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Christoph Maier, Prof. Dr., Study director, Bergmannsheil Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266199
- Sponsor's protocol ID
- VNQI-2012
- Status last verified
- Oct 2014
- First submitted
- 22 Aug 2013
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Questionnaire Regarding Pain Management in Hospitals Using a Qualitative Verification
- ClinicalTrials.gov ID
- NCT02266199
- Acronym / sponsor ID
- VNQI-2012
- Conditions
- Pain
- Keywords
- questionnaire, quality assurance, qualitative Verification, conservative patients, interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative patients | – | –in-patients on pneumology, cardiology, neurology, gastroenterology, endocrinology |
| operative patients | – | –inpatient on Traumatology, Plastic Surgery, Cardiothoracic Surgery, Gynecology, Abdominal Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Signing the consent form
- Patients with acute postoperative pain
- Patients with acute pain with conservative treatment
- Patients with ≥ 18 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Pain intensity
Time frame: 10-60 minutes
Grading of pain management
Time frame: 10-60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Maier, Prof. Dr. study director
Bergmannsheil Bochum
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Ruhr University of Bochum at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview (time frame: 10-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.