Trial Outcomes & Findings for Qualitative Study for Pain Measurement Using Innovative Health Technology (NCT NCT03727373)

NCT ID: NCT03727373

Last Updated: 2020-03-27

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

8 participants

Primary outcome timeframe

1 day (during the interview)

Results posted on

2020-03-27

Participant Flow

Participant milestones

Participant milestones
Measure
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).
Overall Study
STARTED
8
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Qualitative Study for Pain Measurement Using Innovative Health Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Age, Customized
Age
62 years
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
8 Participants
n=5 Participants
Region of Enrollment
Germany
8 participants
n=5 Participants
Type of pain
Acute pain
4 Participants
n=5 Participants
Type of pain
Chronic pain
4 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 day (during the interview)

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

Outcome measures

Outcome measures
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Number of Participants Willing to Assess Their Pain Using Technology
Willing to assess pain using technology
5 Participants
Number of Participants Willing to Assess Their Pain Using Technology
Not willing to assess pain using technology
3 Participants

SECONDARY outcome

Timeframe: 1 day (during the interview)

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

Outcome measures

Outcome measures
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Number of Participants Impaired by Pain During Daily Life
Impaired by pain during daily life
7 Participants
Number of Participants Impaired by Pain During Daily Life
Not impaired by pain during daily life
1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members
Satisfied with pain-assessment by medical staff
5 Participants
Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members
Not satisfied with pain-assessment by med. staff
3 Participants

SECONDARY outcome

Timeframe: 1 day (during the interview)

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

Outcome measures

Outcome measures
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Number of Participants Considering Regular Assessment of Pain Important
Considering regular pain-assessment important
4 Participants
Number of Participants Considering Regular Assessment of Pain Important
Not considering regular pain-assessment important
4 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)
Already using technology
7 Participants
Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)
Not already using technology
1 Participants

SECONDARY outcome

Timeframe: 1 day (during the interview)

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

Outcome measures

Outcome measures
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Number of Participants Willing to Assess Their Pain Themselves
Willing to assess pain themselves
4 Participants
Number of Participants Willing to Assess Their Pain Themselves
Not willing to assess pain themselves
4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician
Willing to use technology (required by physician)
5 Participants
Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician
Not willing to use technology (requ. by physician)
3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Patients With Acute or Chronic Pain
n=8 Participants
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).
Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only
Willing to use technology (own interest only)
2 Participants
Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only
Not willing to use technology (own interest only)
6 Participants

Adverse Events

Patients With Acute or Chronic Pain

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. med. Dirk Rades

Department of Radiation Oncology, University of Lübeck, Germany

Phone: 0049 451 500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place