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Clinical Trials/NCT06460909
NCT06460909
Recruiting
Not Applicable

Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery

Assistance Publique - Hôpitaux de Paris1 site in 1 country180 target enrollmentFebruary 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hallux Valgus Surgery
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
180
Locations
1
Primary Endpoint
Impact of preoperative psychological support on pain catastrophizing
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Catastrophizing is a negative evaluation of events. What surgery concerns, pain catastrophizing is one of the main risks of postoperative pain and / or poor functional recovery. The best survey to evaluate pain catastrophizing is the PCS (Pain Catastrophizing Scale). According to the authors, catastrophizers report more negative pain related thoughts, more emotional distress and more pain than non-catastrophizers. The PCS is a significant predictor of pain intensity and so of poor functional recovery.

It is already well known that anxiety and catastrophizing predict postoperative pain.

The actual studies focus mainly on functional recovery of knee and hip arthroplasties, but less on pain and functional recovery of hallux valgus surgery.

According to several authors, adapted psychological support of preoperative catastrophizing could allow a better postoperative evolution.

Our hypothesis is that a preoperative psychological consultation of catastrophizing patients is efficient to lower pain catastrophizing in adult patients undergoing a surgical operation for hallux valgus.

The first objective is to evaluate the impact of a psychological support of preoperative pain catastrophizing during a hallux valgus surgery.The principal evaluation scale is the pain catastrophizing score before and after surgery.

The second objective is to evaluate the pain and functional recovery of pain catastrophizing patients. The criteria of this survey are: anxiety score (usual and actual), pain and function according to the FAOS (Foot and Ankle Outcome Score) pain (Analogic Visual Scale).

Registry
clinicaltrials.gov
Start Date
February 2, 2023
End Date
February 2, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult over 18
  • Independent, living in its own home
  • Affiliated at a social security
  • Consent signed
  • Waiting for a Hallux Valgus surgery.

Exclusion Criteria

  • Not Able to understand french language
  • Patient refusal
  • Under guardianship
  • Under french AME system

Outcomes

Primary Outcomes

Impact of preoperative psychological support on pain catastrophizing

Time Frame: at baseline

By State portion of the Spielberger State-Trait Anxiety Inventory STAI.

Secondary Outcomes

  • Pain evaluate of catastrophizing patients(at baseline)

Study Sites (1)

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