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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06105281
Other study ID # NURSIPACT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 13, 2023
Est. completion date May 31, 2024

Study information

Verified date October 2023
Source Universiteit Antwerpen
Contact Tamy Bonte, BSN
Phone 0032491514545
Email Tamy.bonte@student.uantwerpen.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 172
Est. completion date May 31, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Belgium Vitaz campus Sint-Niklaas Sint-Niklaas Oost-Vlaanderen

Sponsors (2)

Lead Sponsor Collaborator
Universiteit Antwerpen Vitaz

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavior towards chronic pain Pain solution questionaire (Pasol) by De Vlieger et al. (2006) - Min 0; Max 84 - Higher is better 7 months
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