Nurse-led Pain Education Clinical Trial in Chronic Pain Patients

May 17, 2024 updated by: Filip Haegdorens, Universiteit Antwerpen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard physician led care
Consultation by physician (pain specialist)
Experimental: Nurse-led care
Preclinical nurse-led consultation and standard care by physician (pain specialist)
Behavioral: Nurse-led care by a nurse specialist in pain
A nurse pain specialist consultation in patients in the experimental arm before they receive standard care by a physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient attitude on chronic pain
Time Frame: Up to 10 months
Pain Solutions Questionnaire (PaSol)
Up to 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: Up to 10 months
Core questionnaire for the assessment of patient satisfaction in academic hospitals (COPS)
Up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Bart Morlion, MD PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S65953

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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