Qualitative Study for Pain Measurement Using Innovative Health Technology

Overview

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.

Full Title of Study: “Qualitative Study for Pain Measurement Using Innovative Health Technology (QualiPain)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 23, 2018

Detailed 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Willing to Assess Their Pain Using Technology
    • Time Frame: 1 day (during the interview)
    • Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology.

Secondary Measures

  • Number of Participants Impaired by Pain During Daily Life
    • Time Frame: 1 day (during the interview)
    • Patients were asked during a semi-structured qualitative interview, if they were impaired by pain during their daily life.
  • Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members
    • Time Frame: 1 day (during the interview)
    • 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.
  • Number of Participants Considering Regular Assessment of Pain Important
    • Time Frame: 1 day (during the interview)
    • Patients were asked during a semi-structured qualitative interview, if they were considering regular assessment of their pain important.
  • Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)
    • Time Frame: 1 day (during the interview)
    • 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).
  • Number of Participants Willing to Assess Their Pain Themselves
    • Time Frame: 1 day (during the interview)
    • Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain themselves.
  • Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician
    • Time Frame: 1 day (during the interview)
    • 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.
  • Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only
    • Time Frame: 1 day (during the interview)
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

It is intended to have a balanced inclusion of at least 3 male and 3 female patients.

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Schleswig-Holstein
  • Collaborator
    • European Regional Development Fund
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dirk Rades, MD, Professor Dr. med. – University Hospital Schleswig-Holstein
  • Overall Official(s)
    • Dirk Rades, Prof. Dr., Principal Investigator, Dep. of Radiation Oncology, Univ. Medical Center S-H Campus Lübeck (Germany)

References

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.

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.

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.

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