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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Pain, Chronic; Pain Measurement; Pain, Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Germany
  • Lubeck, Germany, 23562
    • Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Department of Neurosurgery, University Medical Center Schleswig-Holstein Campus Lübeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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:

• Gender: male=3 patients; female=3 patients;
• Age: 18-49 years = 1 patient; 50-79 years = 1 patient; >80 years = 1 patient
• Quality of pain: acute: 2 patients; chronic: 2 patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: Zealand University Hospital; European Regional Development Fund; Design School Kolding
• Investigators: Principal Investigator: Dirk Rades, Prof. Dr., Dep. of Radiation Oncology, Univ. Medical Center S-H Campus Lübeck (Germany)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): November 23, 2018
• Study Completion (Actual): November 23, 2018

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Pain measurement; Health technology; Pain, Cancer; Pain, Chronic or acute
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain; Cancer Pain
• Other Study ID Numbers: QualiPain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No