Pain, ChronicNCT05482152
Nurse-led Pain Education Clinical Trial in Chronic Pain Patients
A study testing Nurse-led care by a nurse specialist in pain in people with Pain, Chronic, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Nurse-led care by a nurse specialist in pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jan 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old
- dutch speaking
- first time consultation
Who cannot join
- Palliative care patients
- Patients with dementia diagnosis
- Urgent referral to the pain clinic by other physicians
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pain, Chronic
- Being tested
- Nurse-led care by a nurse specialist in pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led care by a nurse specialist in painBehavioural
A nurse pain specialist consultation in patients in the experimental arm before they receive standard care by a physician.
| Study group | Role | What they receive |
|---|---|---|
| Standard physician led care | No intervention | Consultation by physician (pain specialist) |
| Nurse-led care | Experimental | Preclinical nurse-led consultation and standard care by physician (pain specialist) Receives: Behavioral: Nurse-led care by a nurse specialist in pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient attitude on chronic pain
Pain Solutions Questionnaire (PaSol)
Measured: Up to 10 months
Secondary outcomes (1)
Patient satisfaction
Core questionnaire for the assessment of patient satisfaction in academic hospitals (COPS)
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start14 Jan 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Filip Haegdorens, Universiteit Antwerpen
- Investigators
- Bart Morlion, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482152
- Sponsor's protocol ID
- S65953
- Status last verified
- May 2024
- First submitted
- 13 Jan 2022
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05482152
- Acronym / sponsor ID
- S65953
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physician led care | No intervention | –Consultation by physician (pain specialist) |
| Nurse-led care | Experimental | Behavioral: Nurse-led care by a nurse specialist in painPreclinical nurse-led consultation and standard care by physician (pain specialist) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old
- dutch speaking
- first time consultation
Key exclusion criteria (3 listed)
- Palliative care patients
- Patients with dementia diagnosis
- Urgent referral to the pain clinic by other physicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led care by a nurse specialist in painA nurse pain specialist consultation in patients in the experimental arm before they receive standard care by a physician. | Behavioural | Nurse-led care |
Primary outcome
Patient attitude on chronic pain
Time frame: Up to 10 months
Pain Solutions Questionnaire (PaSol)
1 secondary outcome
Patient satisfaction
Time frame: Up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Morlion, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led care by a nurse specialist in pain in people with Pain, Chronic, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient attitude on chronic pain (time frame: Up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.