Back to resultsNurse-led Pain Education Clinical Trial in Chronic Pain Patients
Primary Purpose
Pain, Chronic
Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nurse-led care by a nurse specialist in pain
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Chronic
Eligibility Criteria
Inclusion Criteria:
- 18 years old
- dutch speaking
- first time consultation
Exclusion Criteria:
- Palliative care patients
- Patients with dementia diagnosis
- Urgent referral to the pain clinic by other physicians
Sites / Locations
- UZLeuven
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard physician led care
Nurse-led care
Arm Description
Consultation by physician (pain specialist)
Preclinical nurse-led consultation and standard care by physician (pain specialist)
Outcomes
Primary Outcome Measures
Patient attitude on chronic pain
Pain Solutions Questionnaire (PaSol)
Secondary Outcome Measures
Patient satisfaction
Core questionnaire for the assessment of patient satisfaction in academic hospitals (COPS)
Full Information
NCT ID
NCT05482152
First Posted
January 13, 2022
Last Updated
February 9, 2023
Sponsor
Universiteit Antwerpen
Collaborators
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05482152
Brief Title
Nurse-led Pain Education Clinical Trial in Chronic Pain Patients
Official Title
Effect Van Preklinische Nurse-led Neuroscience Pijneducatie op de Attituden Ten Opzichte Van Chronische Pijn en de patiënttevredenheid in Een Universitair Pijncentrum: Een Monocentrische RCT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Not enough participants
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic pain is a multidimensional problem that consequently requires interventions on multiple levels. Pain education by physicians is one of the interventions that shows promising results in patient reported outcomes. It is however unclear if nurse-led chronic pain education could be equally effective on pain attitude and behavior in chronic pain patients. The aim of this clinical trial is to investigate the effects of a nurse-led consultation with chronic pain patients on pain attitude and patient satisfaction compared with regular care without nurse specialist intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard physician led care
Arm Type
No Intervention
Arm Description
Consultation by physician (pain specialist)
Arm Title
Nurse-led care
Arm Type
Experimental
Arm Description
Preclinical nurse-led consultation and standard care by physician (pain specialist)
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led care by a nurse specialist in pain
Intervention Description
A nurse pain specialist consultation in patients in the experimental arm before they receive standard care by a physician.
Primary Outcome Measure Information:
Title
Patient attitude on chronic pain
Description
Pain Solutions Questionnaire (PaSol)
Time Frame
Up to 10 months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Core questionnaire for the assessment of patient satisfaction in academic hospitals (COPS)
Time Frame
Up to 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years old
dutch speaking
first time consultation
Exclusion Criteria:
Palliative care patients
Patients with dementia diagnosis
Urgent referral to the pain clinic by other physicians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Morlion, MD PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZLeuven
City
Leuven
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Nurse-led Pain Education Clinical Trial in Chronic Pain Patients
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