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Completed

NCT Number: NCT03727373

Qualitative Study for Pain Measurement Using Innovative Health Technology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants Willing to Assess Their Pain Using Technology

    Time frame: 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 outcomes

  1. Number of Participants Impaired by Pain During Daily Life

    Time frame: 1 day (during the interview)

    Patients were asked during a semi-structured qualitative interview, if they were impaired by pain during their daily life.

  2. Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members

    Time frame: 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.

  3. Number of Participants Considering Regular Assessment of Pain Important

    Time frame: 1 day (during the interview)

    Patients were asked during a semi-structured qualitative interview, if they were considering regular assessment of their pain important.

  4. Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)

    Time frame: 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).

  5. Number of Participants Willing to Assess Their Pain Themselves

    Time frame: 1 day (during the interview)

    Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain themselves.

  6. Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician

    Time frame: 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.

  7. Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • Design School Kolding
  • European Regional Development Fund
  • Zealand University Hospital

Registry information

Official study title

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

Acronym: QualiPain

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2018
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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