Nurse Specialist Intervention Promoting Altered Coping and Treatment for Chronic Pain (NURSIPACT)

What Impact Does a Consultation With a Nurse Pain Specialist Have on Behaviour Towards Chronic Pain and Pain Intensity in Chronic Pain Patients?

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: The consultation with a pain specialist nurse

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamy Bonte, BSN; Phone Number: 0032491514545; Email: Tamy.bonte@student.uantwerpen.be

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Recruiting
      • Vitaz campus Sint-Niklaas
      • Contact: Tamy Bonte, BN; Email: tamy.bonte@student.uantwerpen.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The participants that only get the standard care in the pain clinic.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: Vitaz
• Investigators: Principal Investigator: Filip Haegdorens, PhD, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: NURSIPACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No