Clinical trial NCT03727373: Qualitative Study for Pain Measurement Using Innovative Health Technology
Official title: Qualitative Study for Pain Measurement Using Innovative Health Technology (QualiPain)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Measurement
Pain, Chronic
Pain, Acute
Pain, Cancer
Keywords: Pain measurement
Pain, Chronic or acute
Pain, Cancer
Health technology
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
name: Zealand University Hospital
name: Design School Kolding
First posted: 2018-11-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Willing to Assess Their Pain Using Technology
timeFrame: 1 day (during the interview)
Secondary outcomes:
measure: Number of Participants Impaired by Pain During Daily Life
timeFrame: 1 day (during the interview)
measure: Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members
timeFrame: 1 day (during the interview)
measure: Number of Participants Considering Regular Assessment of Pain Important
timeFrame: 1 day (during the interview)
measure: Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)
timeFrame: 1 day (during the interview)
measure: Number of Participants Willing to Assess Their Pain Themselves
timeFrame: 1 day (during the interview)
measure: Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician
timeFrame: 1 day (during the interview)
measure: Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only
timeFrame: 1 day (during the interview)
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Department of Neurosurgery, University Medical Center Schleswig-Holstein Campus Lübeck
state: Schleswig-Holstein
city: Lubeck
country: Germany
facility: Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
Study officials:
affiliation: Dep. of Radiation Oncology, Univ. Medical Center S-H Campus Lübeck (Germany)
name: Dirk Rades, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0885-3924(02)00638-3.
citation: 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.
citation: 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).
citation: Kvale, S. & Brinkmann, S. 2009. Interview: Introduktion til et håndværk. Hans Reitzel Kbh.
citation: Rubow, Cecilie. 2003. Samtalen som deltagerobservation. In: Ind i Verden. En Grundbog i Antropologisk Metode.