NCT02266199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2013

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

10 months

First QC Date

August 22, 2013

Last Update Submit

October 12, 2014

Conditions

Keywords

questionnairequality assurancequalitative Verificationconservative patientsinterview

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pain intensity

    10-60 minutes

  • Grading of pain management

    10-60 minutes

Study Arms (2)

conservative patients

in-patients on pneumology, cardiology, neurology, gastroenterology, endocrinology

operative patients

inpatient on Traumatology, Plastic Surgery, Cardiothoracic Surgery, Gynecology, Abdominal Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Signing the consent form
  • Patients with acute postoperative pain
  • Patients with acute pain with conservative treatment
  • Patients with ≥ 18 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bergmannsheil, department for pain management

Bochum, North Rhine-Westphalia, 44789, Germany

Location

Knappschaftskrankenhaus

Langendreer, North Rhine-Westphalia, 44892, Germany

Location

Marienhospital

Witten, North Rhine-Westphalia, 58452, Germany

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Maier, Prof. Dr.

    Bergmannsheil Bochum

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 22, 2013

First Posted

October 16, 2014

Study Start

November 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations