NCT05009316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

August 16, 2021

Last Update Submit

April 8, 2024

Conditions

Keywords

Pain, Chronic

Outcome Measures

Primary Outcomes (4)

  • 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.

    Three days after 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.

    3 months after surgery

  • Persistent post-surgical pain, 6 months

    Using the Short Form of the Brief Pain Inventory, pain intensity will be assessed at 6 months.

    6 months after surgery

  • Pain interference

    Using the Short Form of the Brief Pain Inventory, pain interference on daily activities will be assessed at 6 months.

    6 months after surgery

Study Arms (1)

Questionnaires

EXPERIMENTAL

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

Other: Questionnaires

Interventions

Online-based questionnaires

Questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of NeuroScience (IONS) - UCLouvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • André Mouraux, Ph.D

    Université Catholique de Louvain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 17, 2021

Study Start

September 20, 2021

Primary Completion

December 20, 2023

Study Completion

March 21, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations