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

NCT06460909 | Recruiting

• 2 other identifiers: APHP2203312022-A00381-42
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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).

Conditions

Hallux Valgus Surgery

Keywords

Hallux Valgus Surgery; Psychological Support

Outcome Measures

Primary Outcomes (1)

• Impact of preoperative psychological support on pain catastrophizing

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

  at baseline

Secondary Outcomes (1)

• Pain evaluate of catastrophizing patients

  at baseline

Study Arms (2)

Psychological support arm

EXPERIMENTAL

Patients randomized with psychological intervention.

Other: Psychological support

Without support

NO INTERVENTION

Patients with routine care with psychological support.

Interventions

Psychological support OTHER

An interview with the psychologist before surgery.

Psychological support arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Orthopedia and traumatological department

Boulogne-Billancourt, 92100, France

RECRUITING

Study Officials

• Marie-Hélène Sandiford

  Ambroise Paré hospital - APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Hélène SANDIFORD

CONTACT

+33662148018; mh.sandiford@gmail.com

Alexandre Hardy, MD

CONTACT

+33615101016; alex.hardy.1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 14, 2024
• Study Start: February 2, 2023
• Primary Completion: November 2, 2024
• Study Completion: February 2, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-05

Locations

FR (1)