Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460909
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-30
Brief Title:
Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrePS HV
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 surgeryThe 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
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 surgeryThe 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A00381-42 | REGISTRY | IDRCB | None |