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Pain MeasurementQualiPainNCT03727373

Qualitative Study for Pain Measurement Using Innovative Health Technology

An observational study of Pain Measurement and Pain, Chronic, run by University Hospital Schleswig-Holstein at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain Measurement, Pain, Chronic, Pain, Acute
How many people
8 participants
Where
2 sitesGermany
Study dates
17 Oct 2018to 23 Nov 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 18 years or older
  • Pain intensity > 4 (numeric ranking scale 0-10)
  • Legal capacity
  • Written informed consent

Who cannot join

  • Lack of willingness to cooperate
  • Lack of consent
  • Lack of ability to follow instructions
  • younger than 18 years

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

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

    Lübeck, Schleswig-Holstein, 23538

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

    Lübeck, 23562

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
Pain measurement, Pain, Chronic or acute, Pain, Cancer, Health technology
Medical subject headings
Chronic Pain, Acute Pain, Cancer Pain, Pain, Bronchiolitis Obliterans Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day (during the interview)

Secondary outcomes (7)

  1. 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.

    Measured: 1 day (during the interview)

  2. 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.

    Measured: 1 day (during the interview)

  3. 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.

    Measured: 1 day (during the interview)

  4. 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).

    Measured: 1 day (during the interview)

  5. 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.

    Measured: 1 day (during the interview)

  6. 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.

    Measured: 1 day (during the interview)

  7. 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.

    Measured: 1 day (during the interview)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2018
  2. Study start17 Oct 2018
  3. Primary completion23 Nov 2018
  4. Study completion23 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03727373
Sponsor's protocol ID
QualiPain
Acronym
QualiPain
Status last verified
Mar 2020
First submitted
30 Oct 2018
Last updated
27 Mar 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12614956

  • 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.

    PubMed 17872937

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Pain Measurement and Pain, Chronic, run by University Hospital Schleswig-Holstein at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Willing to Assess Their Pain Using Technology (time frame: 1 day (during the interview)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03727373, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.

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