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| Name | Class |
|---|---|
| European Regional Development Fund | OTHER |
| Zealand University Hospital | OTHER |
| Design School Kolding | OTHER |
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The present study is a multicenter, explorative, qualitative study. The primary endpoint of this study is to evaluate to which extent the collection of data with regard to pain caused by illness or treatment can be optimized using health technology solutions. For this evaluation semi-structured qualitative interviews with 8-10 patients will be conducted.
Secondary variables are the evaluation of the patients' pain experience and the general patients' willingness to collect data with regard to pain by using technological devices themselves or with support of healthcare professionals.
The present multicenter study is an explorative, qualitative study. It shall be evaluated from the patients' point of view if and how the collection of data with regard to pain, caused by illness or treatment, can be optimized using health technology solutions. A health technology solution could for example be an app for registering the intensity and localization of pain. The aim of this study is to examine, if such a solution would be accepted by patients with acute or chronic pain and how a fitting solution should be designed to meet the patients' requirements. Existing methods for pain measurement as well as possibilities for the development of new methods will be examined and evaluated during the interviews.
To arguable this issue the interviews comprise different topics like:
It is the aim to use the results of this study for the development of a new and improved version of pain registration. The results of the study will be summarized in a report and handed over to a startup company. Thereupon the startup company has the possibility to develop a technological solution that represents the patients' need at its best.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Willing to Assess Their Pain Using Technology | Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology. | 1 day (during the interview) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Impaired by Pain During Daily Life | Patients were asked during a semi-structured qualitative interview, if they were impaired by pain during their daily life. | 1 day (during the interview) |
| Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members |
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Inclusion Criteria:
Exclusion Criteria:
It is intended to have a balanced inclusion of at least 3 male and 3 female patients.
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Male and female patients with chronic or actue pain caused by illness or treatment. This pain has to be 4 or higher on a numeric ranking scale (0-10).
The inclusion of patients is planned according to the following sample design:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Rades, Prof. Dr. | Dep. of Radiation Oncology, Univ. Medical Center S-H Campus Lübeck (Germany) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, University Medical Center Schleswig-Holstein Campus Lübeck | Lübeck | Schleswig-Holstein | 23538 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12614956 | Background | Wilkie DJ, Judge MK, Berry DL, Dell J, Zong S, Gilespie R. Usability of a computerized PAINReportIt in the general public with pain and people with cancer pain. J Pain Symptom Manage. 2003 Mar;25(3):213-24. doi: 10.1016/s0885-3924(02)00638-3. | |
| 17872937 | Background | Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Acute or Chronic Pain | Patients included in this study must have had acute or chronic pain with an intensity of >4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Acute or Chronic Pain | Patients included in this study must have had acute or chronic pain with an intensity of >4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Willing to Assess Their Pain Using Technology | Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology. | Posted | Count of Participants | Participants | 1 day (during the interview) |
|
|
1 day (day of the interview)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Acute or Chronic Pain | Patients included in this study must have had acute or chronic pain with an intensity of >4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Dirk Rades | Department of Radiation Oncology, University of Lübeck, Germany | 0049 451 500 | 45401 | dirk.rades@uksh.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2018 | Mar 26, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2018 | Mar 26, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D059787 | Acute Pain |
| D000072716 | Cancer Pain |
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
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Patients were asked during a semi-structured qualitative interview, if they were satisfied with the assessment of their pain when performed by medical staff members. |
| 1 day (during the interview) |
| Number of Participants Considering Regular Assessment of Pain Important | Patients were asked during a semi-structured qualitative interview, if they were considering regular assessment of their pain important. | 1 day (during the interview) |
| Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure) | Patients were asked during a semi-structured qualitative interview, if they were already using technology for assessment of pain or other medical symptoms/outcomes (e.g. blood pressure). | 1 day (during the interview) |
| Number of Participants Willing to Assess Their Pain Themselves | Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain themselves. | 1 day (during the interview) |
| Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician | Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology, if required by their treating physician. | 1 day (during the interview) |
| Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only | Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology, if this was for their own interest only. | 1 day (during the interview) |
| Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein |
| Lübeck |
| 23562 |
| Germany |
| Background | Jaatun, A. A. E. & M. G. Jaatun. 2016. Advanced Healthcare Services Enabled by a Computerized Pain Body Map. The 6th International Conference on Current and Future Trends of Information and Communication Technologies in Healthcare (ICTH 2016). |
| Background | Kvale, S. & Brinkmann, S. 2009. Interview: Introduktion til et håndværk. Hans Reitzel Kbh. |
| Background | Rubow, Cecilie. 2003. Samtalen som deltagerobservation. In: Ind i Verden. En Grundbog i Antropologisk Metode. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of pain | Count of Participants | Participants |
|
|
| Secondary | Number of Participants Impaired by Pain During Daily Life | Patients were asked during a semi-structured qualitative interview, if they were impaired by pain during their daily life. | Posted | Count of Participants | Participants | 1 day (during the interview) |
|
|
|
| Secondary | Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members | Patients were asked during a semi-structured qualitative interview, if they were satisfied with the assessment of their pain when performed by medical staff members. | Posted | Count of Participants | Participants | 1 day (during the interview) |
|
|
|
| Secondary | Number of Participants Considering Regular Assessment of Pain Important | Patients were asked during a semi-structured qualitative interview, if they were considering regular assessment of their pain important. | Posted | Count of Participants | Participants | 1 day (during the interview) |
|
|
|
| Secondary | Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure) | Patients were asked during a semi-structured qualitative interview, if they were already using technology for assessment of pain or other medical symptoms/outcomes (e.g. blood pressure). | Posted | Count of Participants | Participants | 1 day (during the interview) |
|
|
|
| Secondary | Number of Participants Willing to Assess Their Pain Themselves | Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain themselves. | Posted | Count of Participants | Participants | 1 day (during the interview) |
|
|
|
| Secondary | Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician | Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology, if required by their treating physician. | Posted | Count of Participants | Participants | 1 day (during the interview) |
|
|
|
| Secondary | Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only | Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology, if this was for their own interest only. | Posted | Count of Participants | Participants | 1 day (during the interview) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |