Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery
NCT ID: NCT06460909
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-02-02
2025-02-02
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Psychological support arm
Patients randomized with psychological intervention.
Psychological support
An interview with the psychologist before surgery.
Without support
Patients with routine care with psychological support.
No interventions assigned to this group
Interventions
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Psychological support
An interview with the psychologist before surgery.
Eligibility Criteria
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Inclusion Criteria
* Independent, living in its own home
* Affiliated at a social security
* Consent signed
* Waiting for a Hallux Valgus surgery.
Exclusion Criteria
* Patient refusal
* Under guardianship
* Under french AME system
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Marie-Hélène Sandiford
Role: PRINCIPAL_INVESTIGATOR
Ambroise Paré hospital - APHP
Locations
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Orthopedia and traumatological department
Boulogne-Billancourt, , France
Countries
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Central Contacts
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Other Identifiers
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2022-A00381-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
APHP220331
Identifier Type: -
Identifier Source: org_study_id
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