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

April 8, 2024 updated by: Université Catholique de Louvain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Institute of NeuroScience (IONS) - UCLouvain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Questionnaires
Patients will answer online surveys containing different questionnaires that will evaluate psychosocial variables as well as pain variables.
Other: Questionnaires
Online-based questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of acute post-surgical pain
Time Frame: Three days after surgery
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.
Three days after surgery
Development of Persistent post-surgical pain, 3 months
Time Frame: 3 months after surgery
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.
3 months after surgery
Persistent post-surgical pain, 6 months
Time Frame: 6 months after surgery
Using the Short Form of the Brief Pain Inventory, pain intensity will be assessed at 6 months.
6 months after surgery
Pain interference
Time Frame: 6 months after surgery
Using the Short Form of the Brief Pain Inventory, pain interference on daily activities will be assessed at 6 months.
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Collaborators

European Commission

Investigators

  • Study Chair: André Mouraux, Ph.D, Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

March 21, 2024

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POPQUEST

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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