Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery (PrePS HV)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Hallux Valgus Surgery

Treatments: Other: Psychological support

Study type: Interventional

Funder types: Other

Identifiers

NCT06460909

APHP220331

2022-A00381-42 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Psychological support arm

Experimental group

Description:

Patients randomized with psychological intervention.

Treatment:

Other: Psychological support

Without support

No Intervention group

Description:

Patients with routine care with psychological support.