Qualitative Study for Pain Measurement Using Innovative Health Technology

NCT03727373 | Completed Results

• 1 other identifier: QualiPain
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (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.

  1 day (during the interview)

Secondary Outcomes (7)

• Number of Participants Impaired by Pain During Daily Life

  1 day (during the interview)

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

  1 day (during the interview)

• Number of Participants Considering Regular Assessment of Pain Important

  1 day (during the interview)

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

  1 day (during the interview)

• Number of Participants Willing to Assess Their Pain Themselves

  1 day (during the interview)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: It is intended to have a balanced inclusion of at least 3 male and 3 female patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

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

Lübeck, Schleswig-Holstein, 23538, Germany

Location

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

Lübeck, 23562, Germany

Location

Related Publications (5)

• 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.

  PMID: 12614956 BACKGROUND

• 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.

  PMID: 17872937 BACKGROUND

• 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).

  BACKGROUND

• Kvale, S. & Brinkmann, S. 2009. Interview: Introduktion til et håndværk. Hans Reitzel Kbh.

  BACKGROUND

• Rubow, Cecilie. 2003. Samtalen som deltagerobservation. In: Ind i Verden. En Grundbog i Antropologisk Metode.

  BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Acute Pain; Cancer Pain; Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Prof. Dr. med. Dirk Rades
• Organization: Department of Radiation Oncology, University of Lübeck, Germany

dirk.rades@uksh.de

0049 451 500

Study Officials

• Dirk Rades, Prof. Dr.

  Dep. of Radiation Oncology, Univ. Medical Center S-H Campus Lübeck (Germany)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: October 17, 2018
• Primary Completion: November 23, 2018
• Study Completion: November 23, 2018
• Last Updated: March 27, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)