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Qualitative Study for Pain Measurement Using Innovative Health Technology

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03727373
Acronym
QualiPain
Enrollment
8
Registered
2018-11-01
Start date
2018-10-17
Completion date
2018-11-23
Last updated
2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pain measurement, Pain, Chronic or acute, Pain, Cancer, Health technology

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.

Interventions

None listed

Sponsors

European Regional Development Fund
CollaboratorOTHER
Zealand University Hospital
CollaboratorOTHER
Design School Kolding
CollaboratorOTHER
University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Willing to Assess Their Pain Using Technology1 day (during the interview)Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology.

Secondary

MeasureTime frameDescription
Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members1 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 Important1 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 Impaired by Pain During Daily Life1 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 Willing to Assess Their Pain Using Technology, if Required by Treating Physician1 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 Only1 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.
Number of Participants Willing to Assess Their Pain Themselves1 day (during the interview)Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain themselves.

Countries

Germany

Participant flow

Participants by arm

ArmCount
Patients With Acute or Chronic Pain
Patients included in this study must have had acute or chronic pain with an intensity of \>4 on a numeric self-rating scale ranging from 0 to 10 (0=no pain, 10=maximum pain).
8
Total8

Baseline characteristics

CharacteristicPatients With Acute or Chronic Pain
Age, Customized
Age
62 years
Race/Ethnicity, Customized
Caucasian
8 Participants
Region of Enrollment
Germany
8 participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
5 Participants
Type of pain
Acute pain
4 Participants
Type of pain
Chronic pain
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 8
other
Total, other adverse events
0 / 8
serious
Total, serious adverse events
0 / 8

Outcome results

Primary

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.

Time frame: 1 day (during the interview)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patients With Acute or Chronic PainNumber of Participants Willing to Assess Their Pain Using TechnologyWilling to assess pain using technology5 Participants
Patients With Acute or Chronic PainNumber of Participants Willing to Assess Their Pain Using TechnologyNot willing to assess pain using technology3 Participants
Secondary

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).

Time frame: 1 day (during the interview)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patients With Acute or Chronic PainNumber of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)Already using technology7 Participants
Patients With Acute or Chronic PainNumber of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)Not already using technology1 Participants
Secondary

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.

Time frame: 1 day (during the interview)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patients With Acute or Chronic PainNumber of Participants Considering Regular Assessment of Pain ImportantConsidering regular pain-assessment important4 Participants
Patients With Acute or Chronic PainNumber of Participants Considering Regular Assessment of Pain ImportantNot considering regular pain-assessment important4 Participants
Secondary

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.

Time frame: 1 day (during the interview)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patients With Acute or Chronic PainNumber of Participants Impaired by Pain During Daily LifeImpaired by pain during daily life7 Participants
Patients With Acute or Chronic PainNumber of Participants Impaired by Pain During Daily LifeNot impaired by pain during daily life1 Participants
Secondary

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.

Time frame: 1 day (during the interview)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patients With Acute or Chronic PainNumber of Participants Satisfied With Assessment of Pain Performed by Medical Staff MembersSatisfied with pain-assessment by medical staff5 Participants
Patients With Acute or Chronic PainNumber of Participants Satisfied With Assessment of Pain Performed by Medical Staff MembersNot satisfied with pain-assessment by med. staff3 Participants
Secondary

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.

Time frame: 1 day (during the interview)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patients With Acute or Chronic PainNumber of Participants Willing to Assess Their Pain ThemselvesWilling to assess pain themselves4 Participants
Patients With Acute or Chronic PainNumber of Participants Willing to Assess Their Pain ThemselvesNot willing to assess pain themselves4 Participants
Secondary

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.

Time frame: 1 day (during the interview)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patients With Acute or Chronic PainNumber of Participants Willing to Assess Their Pain Using Technology for Their Own Interest OnlyWilling to use technology (own interest only)2 Participants
Patients With Acute or Chronic PainNumber of Participants Willing to Assess Their Pain Using Technology for Their Own Interest OnlyNot willing to use technology (own interest only)6 Participants
Secondary

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.

Time frame: 1 day (during the interview)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patients With Acute or Chronic PainNumber of Participants Willing to Assess Their Pain Using Technology, if Required by Treating PhysicianWilling to use technology (required by physician)5 Participants
Patients With Acute or Chronic PainNumber of Participants Willing to Assess Their Pain Using Technology, if Required by Treating PhysicianNot willing to use technology (requ. by physician)3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026