search
Back to results

Impact of Social Support and Coping Strategies on Post-Surgical Pain (POPQUEST)

Primary Purpose

Social Support, Coping Behavior, Post-Surgical Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Social Support focused on measuring Pain, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged over 18 years of age.
  • Capacity to understand and voluntarily sign an informed consent form in French.

Exclusion Criteria:

  • Insufficient French language skills.
  • History of psychotic disease.
  • History of neurodegenerative pathology.
  • History of neurological disease (e.g. stroke)
  • Pre-existing pain condition related to the reason for surgery

Sites / Locations

  • Institute of NeuroScience (IONS) - UCLouvainRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Questionnaires

Arm Description

Patients will answer online surveys containing different questionnaires that will evaluate psychosocial variables as well as pain variables.

Outcomes

Primary Outcome Measures

Intensity of acute post-surgical pain
Questions from the Short Form of the Brief Pain Inventory (translated in French) will be used to assess the intensity of the pain on a numeric rating scale (from 0 to 10) during the three days following surgery.
Development of Persistent post-surgical pain, 3 months
Using the Short Form of the Brief Pain Inventory, pain will be assessed at three months to determine whether patients will have developed chronic pain.
Persistent post-surgical pain, 6 months
Using the Short Form of the Brief Pain Inventory, pain intensity will be assessed at 6 months.
Pain interference
Using the Short Form of the Brief Pain Inventory, pain interference on daily activities will be assessed at 6 months.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
May 17, 2022
Sponsor
Université Catholique de Louvain
Collaborators
European Commission
search

1. Study Identification

Unique Protocol Identification Number
NCT05009316
Brief Title
Impact of Social Support and Coping Strategies on Post-Surgical Pain
Acronym
POPQUEST
Official Title
Impact of Social Support and Coping Strategies on the Development and Evolution of Post-Surgical Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
March 3, 2024 (Anticipated)
Study Completion Date
March 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
European Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the impact of social support and pain coping strategies in the development and evolution of post-surgical pain.
Detailed Description
This is a longitudinal study. After giving their informed consent, patients will answer online questionnaires assessing pain and different psychosocial variables at these time points: before surgery, one to three days after surgery, and one, three, and six months after surgery. The psychosocial variables evaluated are the following ones : Depression, Anxiety, Stress, Pain Coping Strategies, Social Support, Couple Support.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Support, Coping Behavior, Post-Surgical Pain, Chronic
Keywords
Pain, Chronic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Questionnaires
Arm Type
Experimental
Arm Description
Patients will answer online surveys containing different questionnaires that will evaluate psychosocial variables as well as pain variables.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Online-based questionnaires
Primary Outcome Measure Information:
Title
Intensity of acute post-surgical pain
Description
Questions from the Short Form of the Brief Pain Inventory (translated in French) will be used to assess the intensity of the pain on a numeric rating scale (from 0 to 10) during the three days following surgery.
Time Frame
Three days after surgery
Title
Development of Persistent post-surgical pain, 3 months
Description
Using the Short Form of the Brief Pain Inventory, pain will be assessed at three months to determine whether patients will have developed chronic pain.
Time Frame
3 months after surgery
Title
Persistent post-surgical pain, 6 months
Description
Using the Short Form of the Brief Pain Inventory, pain intensity will be assessed at 6 months.
Time Frame
6 months after surgery
Title
Pain interference
Description
Using the Short Form of the Brief Pain Inventory, pain interference on daily activities will be assessed at 6 months.
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged over 18 years of age. Capacity to understand and voluntarily sign an informed consent form in French. Exclusion Criteria: Insufficient French language skills. History of psychotic disease. History of neurodegenerative pathology. History of neurological disease (e.g. stroke) Pre-existing pain condition related to the reason for surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Matej RINAUDO, M.D.
Phone
+32496232399
Email
carlo.rinaudo@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud Steyaert, M.D.
Email
arnaud.steyaert@student.uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Mouraux, Ph.D
Organizational Affiliation
Université Catholique de Louvain
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of NeuroScience (IONS) - UCLouvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Matej RINAUDO, M.D.
Phone
+32496232399
Email
carlo.rinaudo@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Arnaud Steyaert, M.D.
Email
arnaud.steyaert@student.uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Social Support and Coping Strategies on Post-Surgical Pain

We'll reach out to this number within 24 hrs