Qualitative Study for Pain Measurement Using Innovative Health Technology

Pain, Acute Clinical Trial

— QualiPain  

Official title:

Qualitative Study for Pain Measurement Using Innovative Health Technology (QualiPain)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727373
• Other study ID #: QualiPain
• Status: Completed
• Start date: October 17, 2018
• Est. completion date: November 23, 2018

Study information

• Verified date: March 2020
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

• the patients pain experience in everyday life, e.g. how the patients cope with pain in everyday life and how and if this is documented;

• experiences with and the thought of regular pain recording;

• an evaluation if patients tend to be willing to record their pain using technological devices by themselves or rather with support of healthcare professionals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 23, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Pain intensity > 4 (numeric ranking scale 0-10)

• Legal capacity

• Written informed consent

Exclusion Criteria:

• Lack of willingness to cooperate

• Lack of consent

• Lack of ability to follow instructions

• younger than 18 years

Related Conditions & MeSH terms

• Acute Pain
• Cancer Pain
• Chronic Pain
• Pain Measurement
• Pain, Acute
• Pain, Cancer
• Pain, Chronic

Locations

Country	Name	City	State
Germany	Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein	Lubeck
Germany	Department of Neurosurgery, University Medical Center Schleswig-Holstein Campus Lübeck	Lübeck	Schleswig-Holstein

Sponsors (4)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Design School Kolding, European Regional Development Fund, Zealand University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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).

Kvale, S. & Brinkmann, S. 2009. Interview: Introduktion til et håndværk. Hans Reitzel Kbh.

Rubow, Cecilie. 2003. Samtalen som deltagerobservation. In: Ind i Verden. En Grundbog i Antropologisk Metode.

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. Epub 2007 Sep 14. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 day (during the interview)
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.	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.	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.	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).	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.	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.	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.	1 day (during the interview)