Qualitative Study for Pain Measurement Using Innovative Health Technology

NCT ID: NCT03727373

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2018-11-23

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.

Conditions

Pain Measurement; Pain, Chronic; Pain, Acute; Pain, Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Regional Development Fund

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Design School Kolding

OTHER

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dirk Rades, MD

Professor Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk Rades, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Radiation Oncology, Univ. Medical Center S-H Campus Lübeck (Germany)

Locations

Department of Neurosurgery, University Medical Center Schleswig-Holstein Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein

Lübeck, , Germany

Countries

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.

Reference Type: BACKGROUND

PMID: 12614956 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17872937 (View on PubMed)

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).

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

QualiPain

Identifier Type: -

Identifier Source: org_study_id