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

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ClinicalTrials.gov Identifier: NCT03727373
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
European Regional Development Fund
Region Zealand, Production, Research and Innovation
Design School Kolding
Information provided by (Responsible Party):
Prof. Dirk Rades, MD, University of 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.


Condition or disease
Pain Measurement Pain, Chronic Pain, Acute 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.


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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Qualitative Study for Pain Measurement Using Innovative Health Technology (QualiPain)
Actual Study Start Date : October 17, 2018
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : November 23, 2018



Primary Outcome Measures :
  1. Evaluate to which extent the collection of data with regard to pain caused by illness or treatment can be optimized using health technology solutions [ Time Frame: During the interview ]
    Evaluation 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. For this evaluation semi-structured qualitative interviews with 8-10 patients will be conducted.


Secondary Outcome Measures :
  1. Patients pain experience [ Time Frame: During the interview ]
    Determination of the patients pain experience. For this evaluation semi-structured qualitative interviews with 8-10 patients will be conducted.

  2. General patients' willingness to collect data with regard to pain by using technological devices themselves or with Support of healthcare professionals. [ Time Frame: During the interview ]
    Evaluation if the patients' in general would be willing to collect data with regard to pain by using technological devices themselves or with support of healthcare professionals. For this evaluation semi-structured qualitative interviews with 8-10 patients will be conducted.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   It is intended to have a balanced inclusion of at least 3 male and 3 female patients.
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727373


Locations
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Germany
Department of Neurosurgery, University Medical Center Schleswig-Holstein Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
Lubeck, Germany, 23562
Sponsors and Collaborators
University of Schleswig-Holstein
European Regional Development Fund
Region Zealand, Production, Research and Innovation
Design School Kolding
Investigators
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Principal Investigator: Dirk Rades, Prof. Dr. Dep. of Radiation Oncology, Univ. Medical Center S-H Campus Lübeck (Germany)

Publications:
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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Responsible Party: Prof. Dirk Rades, MD, Professor Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03727373     History of Changes
Other Study ID Numbers: QualiPain
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dirk Rades, MD, University of Schleswig-Holstein:
Pain measurement
Pain, Chronic or acute
Pain, Cancer
Health technology
Additional relevant MeSH terms:
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Acute Pain
Chronic Pain
Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms