Qualitative Study for Pain Measurement Using Innovative Health Technology (QualiPain)
Conditions: Pain Measurement, Pain, Chronic, Pain, Acute, Pain, Cancer
Sponsor: University Hospital Schleswig-Holstein

Study protocol: QualiPain 
 
 
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Study protocol 
 
 
 
Title: Qualitative Study on Pain Registration through Innovative Health Technology 
(QualiPain) 
 
 
 
 
 
 
 
29.09.2018, Version 2.0 
 
 
 
 
 
 
 
 
 
The information in this study protocol is to be treated as strictly confidential. It only serves to 
inform the sponsor, the examiners, the study staff, the ethics committee, the authorities and the 
patients. This study protocol may not be passed on to third parties without the consent of the 
sponsor or the head of the clinical trial. 
 
 
 
 
 

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I. Signatures 
 
 
 
Prof. Dr. med. Dirk Rades (Lead investigator, medical contact person – 
responsible for the conduction of the study) 
 
 
 
 
 
___ 
 
Signature 
 
Date 
 
 
 
 
 
 
 
Dr. Matteo Bonsanto (Contact person Department of Neurosurgery) 
 
 
 
 
 
___ 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 

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Content 
Study protocol .................................................................................................................................... 1 
I. 
Signatures ................................................................................................................................... 2 
II.      Synopsis ..................................................................................................................................... 4 
1. 
Responsibilities .......................................................................................................................... 6 
2. 
Objective and rationale of the study ......................................................................................... 8 
3. 
Recruitment of patients ............................................................................................................. 9 
4. 
Inclusion and exclusion criteria .................................................................................................. 9 
5. 
Study type ................................................................................................................................ 10 
6. 
Study plan ................................................................................................................................ 10 
7. 
Adverse events / serious adverse events ................................................................................. 11 
8. 
Data acquisition and documentation ....................................................................................... 11 
9. 
Results and evaluation ............................................................................................................. 11 
10.    Time schedule .......................................................................................................................... 12 
11.    Conduction of the study .......................................................................................................... 12 
12.    Registration of the study ......................................................................................................... 12 
13.    References ............................................................................................................................... 13 
 
 
 
 

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II. Synopsis 
Sponsor 
University Hospital Schleswig-Holstein (UKSH), Campus Lübeck 
Lead investigator 
Prof. Dr. med. Dirk Rades, Chief Physician of the Department of Radiotherapy
at the University of Lübeck 
Title 
Qualitative Study on Pain Registration through Innovative Health Technology 
Acronym 
QualiPain 
Indication 
Patients with chronic or acute pain related to illness or treatment who rate 
their pain as 4 or higher on the Numerical Rating Scale (NRS). 
Phase 
Not applicable 
Treatment 
No treatment of the patients is planned in connection to this qualitative study. 
The study is limited to the conduction of qualitative interviews. The usual pain 
therapy is not affected by this study. 
Primary objective 
Evaluation if and how the registration of pain related to illness or treatment 
can be improved through the use of health technological solutions from a 
patient perspective.  
Secondary objectives 
1. 
Investigation of the patient experience of pain
2. 
An evaluation of if patients would be willing to register pain assisted by 
health technological devices, either themselves or assisted by health care 
professionals. 
Study design 
It is an explorative, qualitative study. 
It is a multi-centric study that is conducted in a total of three clinics in 
Denmark and Germany.  
Study population 
Inclusion criteria: 
Patients who meet all of the following criteria can be included in the study: 
• 
18 years or older 
• 
Pain Intensity > 4 (Numerical Rating Scale 0-10)  
• 
Legally competent 
• 
Signed declaration of consent 
Exclusion criteria: 
Patients are not included if: 
• 
Lack of willingness to cooperate 
• 
Lack of consent 
• 
Lack of ability to follow instructions 
• 
Younger than 18 years 
Study duration and 
timeframe 
Start of patient recruitment:  September 2018
End of patient recruitment: November 2018 
Data analysis and reporting: September – December 2018 
Duration of interview per patient: approximately 30 minutes 
Number of 
participants 
An inclusion of 8-10 patients is planned.   

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Number of centers 
A total of 3 centers will participate in the study. 
 
Statistical methods 
As this is a qualitative study, no statistical methods will be applied.  
GCP Conformity 
The present study will be conducted according to the current version of the 
internationally approved guidelines for Good Clinical Practice (ICH-GCP).  
Financing 
The study is a subproject of the third-party funded project InnoCan. InnoCan is 
funded by the European Regional Development Fund as part of the Interreg 
Deutschland-Danmark program. 
 
 
 

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1. Responsibilities 
Sponsor: 
University Hospital Schleswig-Holstein (UKSH), Campus Lübeck 
Ratzeburger Allee 160, 23538 Lübeck, Deutschland 
 
Financing: 
The study is funded by the third-party funded EU (Interreg) project InnoCan. 
 
Lead Investigator / medical contact person: 
The responsibility for this study is placed at the Department of Radiotherapy, Lübeck 
University (Prof. Dr. Rades). The Department of Radiotherapy in Lübeck is part of both 
the University of Lübeck and the University Hospital Schleswig-Holstein (UKSH). The 
clinic will help recruit patients on its own ward.  
University Hospital Schleswig-Holstein (UKSH), Campus Lübeck 
Represented by: 
Prof. Dr. med. Dirk Rades 
Department of Radiotherapy  
Lübeck University 
Ratzeburger Allee 160, 23538 
Tel: +49-451 500-45400 
Fax: +49-451 500-45404 
E-Mail: dirk.rades@uksh.de 
 
Department involved in the study on site:  
The Department of Neurosurgery at Lübeck University treats a large number of patients 
with acute and chronic pain. The clinic will help recruit patients on its own ward.  
Contact person:  
Dr. med. Matteo Bonsanto  
Ratzeburger Allee 160, 23538 
Tel: +49-451 500-43211 
E-Mail: matteo.bonsanto@uksh.de 
 
Danish study center: 
The oncological department of the Zealand University Hospital in Næstved will function as 
a Danish study center. Patients with pain due to illness or treatment are also here invited 
to take part in 30-minute qualitative interviews. The interviews in Denmark and Germany 
are based on the same interview guide. 
 
Contact person: 
Senior physician Niels Henrik Holländer 
Department of oncology and palliative unit 

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Zealand University Hospital 
Rådmandsengen 5 
DK-4700 Næstved 
Tel: +45 56 51 39 12 
E-Mail: nhho@regionsjaelland.dk  
 
Conduction of qualitative Interviews: 
The Department Production, Research and Innovation (PFI) at the Region Zealand, 
Denmark has in depth experience with the support of innovative projects and research at 
Danish and German hospitals. Currently PFI is a project partner in the Interreg 5a project 
Innocan – Innovative high technological cancer treatment Denmark – Germany. 
Furthermore, PFI has great competencies in medical anthropology. PFI will conduct 
qualitative interviews with the participating patients. German is the native language of the 
interviewer.   
Contact person: 
Frederike Fahse 
Production, Research and Innovation, Region Zealand 
Alleen 15  
DK-4180 Sorø 
Tel: +45 93 56 73 85 
E-Mail: ffah@regionsjaelland.dk 
 
 
Design expertise: 
The Designschool Kolding (DSK) in Denmark will participate in the interviews with their 
expertise in the field of design. It will contribute with in depth design and user experience 
(UX) expertise to the study. The DSK has the competencies to communicate and visualize 
future-oriented designs of e.g. apps or other technical devices and to design them in such a 
way that they can be integrated as well as possible into the everyday life of users. 
Contact person:  
Ingrid van Rijn 
Designschool Kolding 
Ågade 10 
DK-6000 Kolding 
Tel: +45 50 10 33 99 
E-Mail: ias@dskd.dk 
 
 
 
 
 
 
 
 
 
 
 

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2. Objective and rationale of the study 
The study aims to investigate whether and how the registration of pain related to disease 
or treatment can be optimized through the application of health technology solutions from 
a patient’s perspective. A health technology solution could e.g. be an app or a device to 
measure vital signs. The objective of this study is to investigate if such a solution would be 
accepted by patients with acute or chronic pain, and how a suitable solution should be 
designed to meet the needs of the patient. Existing methods for pain registration as well as 
opportunities for the development of new methods will be investigated and evaluated in 
the interviews. 
In order to investigate this question, the interview contains several topics, including: 
• 
The patient’s everyday experience of pain, e.g. how patients cope with every day 
pain and if they document their pain. 
• 
Experiences with and thoughts about a regular recording of pain. 
• 
An evaluation of if patients would be willing to register pain assisted by health 
technological devices, either themselves or assisted by health care professionals. 
The goal of the study is that the results can aid in the development of a new and improved 
form of pain registration. The results of the study are summarized in a report to the 
startup company Nextlabel OHG that will have the opportunity to develop a technological 
solution tailored to the needs of the patient. 
Background  
According to the German Pain Association (Deutsche Schmerzgesellschaft e.V.), around 23 
million Germans live with chronic pain. Pain is also a common side effect in cancer 
patients that undergo radiotherapy.  
International studies have shown that digital pain registration provides some benefits for 
patients and medical staff. For example, a Norwegian study has found that a digital 
solution help patients with late-stage cancer to communicate their pain to others, and thus 
improves communication with medical professionals1. Another study has shown that the 
digital solution enables patients to record pain more independently of medical personnel, 
which is generally considered an advantage by patients2. These studies mainly relate to 
information, where patients have used technology themselves. 
To open up for new perspectives for the use of health technologies in hospital 
departments, it is important to involve users at the very beginning of the development 
process. Therefore, we will conduct qualitative interviews with patients about their pain 
experience in their everyday lives and their wishes to future pain registration. 
Own preparatory work 
Preparing for this study nine informative talks were conducted with doctors, nurses and 
physiotherapists from the Radiotherapy Clinic at the University of Lübeck, the Clinic for 
Radiotherapy at the University of Kiel and the Clinic for Neurosurgery at the University of 
                                                          
1 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).  
2 Wilkie, DJ et al. 2003. Usability of a Computerized PAINReportIt in the General Public with Pain and People 
with Cancer Pain. Journal of Pain and Symptom Management Vol 25(3). 

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Lübeck. These conversations revealed that there is no uniform approach to pain 
registration, even though a detailed and continuous registration potentially can improve 
the diagnosis and treatment of pain and generate relevant data for research. Existing 
forms of pain registration include the Numerical Rating Scale (NRS), the Visual Analogue 
Scale (VAS), pain diaries and questionnaires about the treatment pathways. 
A more detailed description of the applied methods can be found in section 6. 
 
3. Recruitment of patients 
This study includes patients who have chronic or temporary pain related to illness or 
treatment. The patients are recruited in two ways: 
Firstly, a brochure (Appendix 1) will be laid out in the waiting areas of the clinic for 
Radiotherapy and the Clinic for Neurosurgery at the University of Lübeck. Interested 
patients then have the opportunity to call or e-mail a contact person, who informs them in 
person about the course of the study. After informing about the study a doctor who takes 
part in the project hands out patient information and a copy of the declaration of consent, 
which needs to be signed by the patient and the doctor (Appendix 2). 
Secondly, patients treated by the research doctors in the clinics are approached and 
informed about the study. If the patient is interested in participating, the patient 
information and the declaration of consent as described above are handed to the doctor. 
Then an interview appointment is agreed upon. 
Only patients who are at least 18 years old and who themselves experience that pain 
affects and limits their everyday life are included. The patients have the opportunity to 
withdraw their consent at any time, whereupon every data collected is deleted 
immediately or anonymized at the patient's request. An anonymization of data may be 
necessary if the patient has already been interviewed at the time of drop-out. 
8-10 patients are enrolled in the study. The participating patients receive no financial 
compensation. Patients are included in the studies according to the qualitative sampling 
plan shown in Table 1. 
Table 1: Qualitative sampling plan 
Sex 
Age  
Pain Quality 
Male 
Female 
18-49 
50-79 
>80 
Acute 
Chronic 
3 
3 
1 
1 
1 
2 
2 
 
4. Inclusion and exclusion criteria 
Inclusion criteria: 
Patients who meet all of the following criteria can be included in the study: 
• 
18 years or older 

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• 
Pain Intensity > 4 (Numerical Rating Scale 0-103)  
• 
Legally competent 
• 
Signed declaration of consent 
Exclusion criteria: 
Patients are not included if: 
• 
Lack of willingness to cooperate 
• 
Lack of consent 
• 
Lack of ability to follow instructions 
• 
Younger than 18 years 
 
5. Study type 
It is an explorative qualitative study. 
The study is multi-centric and takes place in Denmark and Germany in a total of three 
clinics. From September to November 2018, patients will be interviewed once using a 
standardized interview guide. The duration of the interview is approximately half an hour. 
Upon completion of the interviews no further patient related activities will take place as 
part of the study. 
 
6. Study plan 
In order to be create a good communication with the patient, a semi-structured interview 
format is used4 5. The interviews have no direct influence on the diagnosis or treatment of 
the patients and thus no modification to the standard therapy is made.  
An anthropologist from PFI as well as a design engineer from DSK will conduct the semi-
structured interview individually or together. Since it is an explorative study, the interview 
is based on a thematic interview guide (Appendix 3). This gives the patient the opportunity 
to talk about topics that are important to him or her. At the beginning of the interviews, 
the participants are provided with a brief introduction to the study to make sure they are 
informed and feel comfortable with the interview situation. The subsequent questions 
provide the participants with the opportunity to share their experiences from their own 
perspective. It is important that the questions are posed in an understandable language. 
The interviewer ensures that all relevant topics are covered during the interview period. 
Visual aids can also be used to evaluate whether patients would be willing to use 
technological devices to self-register or for registration assisted by medical specialists. 
Two documents have been created by the Design School Kolding to provide visual aid 
during the interview (Appendix 5). 
 
                                                          
3 Anhang 4 
4 Kvale, S. & Brinkmann, S. 2009. Interview: Introduktion til et håndværk. Hans Reitzel Kbh.   
5 Rubow, Cecilie. 2003. Samtalen som deltagerobservation. In: Ind i Verden. En Grundbog i Antropologisk 
Metode.  

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Both documents are only intended as a visual supplement to the interview guide. The 
patient has the opportunity to comment on the documents, thereby making the documents 
the starting point for further reflections and discussion with the patient. Through the use 
of qualitative methods and visual aids, the user (here: the patient) is put in the center and 
it is taken into account how changes (e.g. the use of new products, systems or services) in 
the everyday life of the user can create meaning and can be integrated as good as possible. 
 
7. Adverse events / serious adverse events 
The patient's involvement is reduced to the interview. For this reason, there are not 
expected any adverse events relevant to the study. If participating in an interview is a 
psychological burden for the patient, the patient is at all times free to stop participation 
without giving a reason. 
 
8. Data acquisition and documentation 
Information on the age and gender of the participants is recorded in connection to every 
interview. Interviews are recorded using a dictaphone after patient consent and 
pseudomized through the assignment of a number. The personal data of the participating 
patients are recorded in a patient identification log and are kept inaccessible to third 
parties in the department of radiotherapy even after the study has been completed. All 
study results are anonymized and summarized in a final report. The report will be 
forwarded to Nextlabel OHG after completion of the study. Except for the final report, 
Nextlabel OHG does not receive any of the collected data. A scientific article may be 
published subsequently. All interview excerpts used in the article will be completely 
anonymized. 
The data collected in the interviews will be kept at PFI for analysis purposes and will be 
completely anonymized after the end of the study and no later than December 31, 2018. 
All contact details of the participating patients are kept in the Department of Radiotherapy 
in Lübeck. The study-specific data are stored/archived for a period of 10 years. 
There is no electronic data transfer. Instead data transmission takes place through the 
personal exchange of encrypted USB sticks. The data collection and storage of data take 
place in agreement with the General Data Protection Regulation (GDPR [2016/679]). 
 
9. Results and evaluation 
The recordings of the qualitative interviews are analyzed and the results are summarized 
in an anonymized report. For the analysis, detailed notes on the sound recordings are 
written, and, if necessary, the interviews are partially transcribed. Subsequently, a 
thematic analysis is carried out to identify important topics of the interviews. It is 
evaluated, among other things, to what extent patients are already registering pain, e.g. 
with the help of an app or analogue and what possibilities there are for digital registrations 
in the future. 
In addition, new and as of yet unknown, subject areas can be identified in the analysis, 
which can contribute to the development of an improved method for pain detection. The 

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results of the qualitative analysis result in recommendations for the development of a pain 
app or other technological solution for pain registration. The technological solution 
developed can then be tailored precisely to the needs of the patients in the participating 
clinics. A scientific article may be published after the study is completed. 
 
10. Time schedule 
Timespan 
Action 
September-November 2018 
Patient recruitment and interviews 
September-December  2018 
Data analysis and reporting 
 
11. Conduction of the study 
The study protocol as well as possible later changes to the protocol have been or will be 
written according to the Helsinki Declaration version from October 1996 (48th General 
Assembly of the World Medical Association, Somerset West, Republic of South Africa). 
Possible later changes to the study protocol will be send to the ethical committee as an 
amendment.  
The study is conducted in accordance with the principles of the Good Clinical Practice 
(ICH-GCP) guideline. 
The quality criteria for qualitative studies which are summarized in the guideline for 
publication of qualitative research results “Consolidated criteria for reporting qualitative 
research” (COREQ) [6] are considered in this study. The presentation of the study 
methodology and results will be based on the COREQ criteria. 
Insurance 
No special insurance protection (patient insurance) is required for the patients involved in 
the study. No commuting accident insurance has been made. 
Benefit-risk-assessment 
No risk is to be expected from the questioning of the patients, since patient participation is 
limited to the qualitative interview. 
 
 
12. Registration of the study 
The study will be registered at https://clinicaltrials.gov before study start. 
 
 
 

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13. References 
1. 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).  
2. Wilkie, DJ et al. 2003. Usability of a Computerized PAINReportIt in the General 
Public with Pain and People with Cancer Pain. Journal of Pain and Symptom 
Management Vol 25(3). 
3. Anhang 4 
4. Kvale, S. & Brinkmann, S. 2009. Interview: Introduktion til et håndværk. Hans Reitzel 
Kbh. 
5. Rubow, Cecilie. 2003. Samtalen som deltagerobservation. In: Ind i Verden. En 
Grundbog i Antropologisk Metode. 
6. 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; 19: 349-357. 
 
 
 
 
 
 
 
 
Dieses Projekt wird gefördert mit Mitteln des Europäischen Fonds für regionale Entwicklung.