QualiPain: Qualitative Study for Pain Measurement Using Innovative Health Technology

• Sponsor: University Hospital Schleswig-Holstein (Other)
• Overall Status: Completed
• CT.gov ID: NCT03727373
• Collaborator: European Regional Development Fund (Other), Zealand University Hospital (Other), Design School Kolding (Other)
• Enrollment: 8
• Locations: 2
• Actual Duration (Months): 1.2
• Patients Per Site: 4
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 8 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Qualitative Study for Pain Measurement Using Innovative Health Technology (QualiPain)
• Actual Study Start Date: Oct 17, 2018
• Actual Primary Completion Date: Nov 23, 2018
• Actual Study Completion Date: Nov 23, 2018

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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).

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery, University Medical Center Schleswig-Holstein Campus Lübeck	Lübeck	Schleswig-Holstein	Germany	23538
2	Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein	Lubeck		Germany	23562

Sponsors and Collaborators

• University Hospital Schleswig-Holstein
• European Regional Development Fund
• Zealand University Hospital
• Design School Kolding

Investigators

• Principal Investigator: Dirk Rades, Prof. Dr., Dep. of Radiation Oncology, Univ. Medical Center S-H Campus Lübeck (Germany)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 29, 2018
• Informed Consent Form - Jul 30, 2018

More Information

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.
• 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. Epub 2007 Sep 14.
• 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.

• Responsible Party: Prof. Dirk Rades, MD, Professor Dr. med., University Hospital Schleswig-Holstein
• ClinicalTrials.gov Identifier: NCT03727373
• Other Study ID Numbers: QualiPain
• First Posted: Nov 1, 2018
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Professor Dr. med., University Hospital Schleswig-Holstein: Pain measurement; Pain, Chronic or acute; Pain, Cancer; Health technology
• Additional relevant MeSH terms: Acute Pain; Chronic Pain; Cancer Pain

Study Results

Participant Flow

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Overall Participants	8
Age, Customized (years) [Median (Full Range) ]
Age	62
Sex: Female, Male (Count of Participants)
Female	3 37.5%
Male	5 62.5%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	8 100%
Region of Enrollment (participants) [Number]
Germany	8 100%
Type of pain (Count of Participants)
Acute pain	4 50%
Chronic pain	4 50%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Willing to Assess Their Pain Using Technology
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Measure Participants	8
Willing to assess pain using technology	5 62.5%
Not willing to assess pain using technology	3 37.5%

2. Secondary Outcome

Title	Number of Participants Impaired by Pain During Daily Life
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Measure Participants	8
Impaired by pain during daily life	7 87.5%
Not impaired by pain during daily life	1 12.5%

3. Secondary Outcome

Title	Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Measure Participants	8
Satisfied with pain-assessment by medical staff	5 62.5%
Not satisfied with pain-assessment by med. staff	3 37.5%

4. Secondary Outcome

Title	Number of Participants Considering Regular Assessment of Pain Important
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Measure Participants	8
Considering regular pain-assessment important	4 50%
Not considering regular pain-assessment important	4 50%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Measure Participants	8
Already using technology	7 87.5%
Not already using technology	1 12.5%

6. Secondary Outcome

Title	Number of Participants Willing to Assess Their Pain Themselves
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Measure Participants	8
Willing to assess pain themselves	4 50%
Not willing to assess pain themselves	4 50%

7. Secondary Outcome

Title	Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Measure Participants	8
Willing to use technology (required by physician)	5 62.5%
Not willing to use technology (requ. by physician)	3 37.5%

8. Secondary Outcome

Title	Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
Measure Participants	8
Willing to use technology (own interest only)	2 25%
Not willing to use technology (own interest only)	6 75%

Adverse Events

Time Frame	1 day (day of the interview)
Arm/Group Title	Patients With Acute or Chronic Pain
Arm/Group Description	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).
All Cause Mortality
	Patients With Acute or Chronic Pain
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	Patients With Acute or Chronic Pain
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Patients With Acute or Chronic Pain
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.