Qualitative Study for Pain Measurement Using Innovative Health Technology

Completed

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

• Registration Number: NCT03727373
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2018-10-17
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-01
• Primary Completion: 2018-11-23
• Study Completion: 2018-11-23
• Results First Submitted: 2020-02-11
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Results First Posted: 2020-03-27
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Willing to Assess Their Pain Using Technology	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 Outcome Measures

Name	Time	Method
Number of Participants Impaired by Pain During Daily Life	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	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	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)	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	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	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	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.

Trial Locations

Locations (2)

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, Germany