Nurse Specialist Intervention Promoting Altered Coping and Treatment for Chronic Pain

NCT ID: NCT06105281

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to investigate of the implementation of an autonomous consultation with a nurse pain specialist for chronic pain patients has an influence on the behaviour towards the chronic pain. The trail will be done with patients that has planned an infiltration in a pain centre. Furthermore the pain intensity and patent satisfaction will be investigated as second outcomes.

During the consultation there will be explained what the patient can expect from the treatment in the pain clinic. What the patient expect from the infiltration will also be surveyed, so that it can be adjusted if necessary. In the end of the consultation there will be a brief explanation of chronic pain and the physiology as well als the different factors that have an influence on it.

This study is a monocentric randomised controlled trail of 172 participants, with an equal allocation (1:1). To collect the data there will be three different questionnaires for both groups. The first is a baseline measurement. The second will take place three weeks after the infiltration and the third ten weeks after the infiltration. This is in order to see if there is an evolution in the outcomes during time.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Monocentric Randomised controlled trail in the Vitaz Hospital of Sint-Niklaas. It will take place at the pain clinic where patient with chronic pain come for a treatment or infiltration against chronic pain. There will be two groups of patients, an intervention and an control arm with an equal allocation (1:1). The intervention and control arm will complete the study simultaneous. In each group will count 86 participance at the begin of the trail. This give us the possibility of 35% loss of follow up in each group, so that we can end the study with 64 participants in each group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

The participants that only get the standard care in the pain clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

The consultation with a pain specialist nurse

When the participant receives a consultation with the pain specialist nurse ,there will be assessed if the patient knows what the procedure involves and what they can expect of it. To meet de expectations of the patient the nurse will explain the procedure and what they can expect. Further there will be an short education about what pain is and the physiology of chronic pain. Because chronic pain has a lot of influencing factors the nurse will explain the main factors.

Group Type EXPERIMENTAL

The consultation with a pain specialist nurse

Intervention Type BEHAVIORAL

When the participant receives a consultation with the pain specialist nurse ,there will be assessed if the patient knows what the procedure involves and what they can expect of it. To meet de expectations of the patient the nurse will explain the procedure and what they can expect. Further there will be an short education about what pain is and the physiology of chronic pain. Because chronic pain has a lot of influencing factors the nurse will explain the main factors.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The consultation with a pain specialist nurse

When the participant receives a consultation with the pain specialist nurse ,there will be assessed if the patient knows what the procedure involves and what they can expect of it. To meet de expectations of the patient the nurse will explain the procedure and what they can expect. Further there will be an short education about what pain is and the physiology of chronic pain. Because chronic pain has a lot of influencing factors the nurse will explain the main factors.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients that have an appointment for a treatment
* Patients with chronic pain, so 3 months or more and of functional dysfunction because of the pain.
* Patients that are receiving a spinal treatment form the cervical, thoracic or lumbar spine.
* The patient has to understand the Dutch language.

Exclusion Criteria

* Patients with a neurostimulator, an intrathecal medication pump or patients that already has an appointment at the consultation in the pain clinic. They have an doctor- patient relationship and that can cause bias.
* People who are legally incapable (persons younger then 18 years, persons with dementia, other cognitive diseases.
* People with facial pain. Here is the necessity of quick treatments. Or they already take place in other studies.
* People who are interned or detained. There is no possibility of follow-up.
* Palliative, oncologic or in hospital patients
* Patients who need a emergency treatment, because it is mostly acute or sub acute pain.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vitaz

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Filip Haegdorens

prof. dr. (PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Filip Haegdorens, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vitaz campus Sint-Niklaas

Sint-Niklaas, Oost-Vlaanderen, Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tamy Bonte, BSN

Role: CONTACT

0032491514545

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tamy Bonte, BN

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NURSIPACT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.