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

Sponsor

Universiteit Antwerpen (Other)

Overall Status

Recruiting

CT.gov ID

NCT06105281

Collaborator

Vitaz (Other)

172

Enrollment

Location

Arms

7.6

Anticipated Duration (Months)

22.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: The consultation with a pain specialist nurse	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 13, 2023

Anticipated Primary Completion Date :

May 30, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vitaz campus Sint-Niklaas	Sint-Niklaas	Oost-Vlaanderen	Belgium	9100

Sponsors and Collaborators

Universiteit Antwerpen
Vitaz

Investigators

Principal Investigator: Filip Haegdorens, PhD, Universiteit Antwerpen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Filip Haegdorens, prof. dr. (PhD), Universiteit Antwerpen

ClinicalTrials.gov Identifier:

NCT06105281

Other Study ID Numbers:

NURSIPACT

First Posted:

Oct 27, 2023

Last Update Posted:

Oct 27, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Oct 27, 2023