An interventional study of Psychological support in Hallux Valgus Surgery, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
Among 17 studies in Hallux Valgus with a site in France — 3 open to participants now, 5 under way, none of them phase 3. Hallux Valgus · France.
Among the 17 studies in Hallux Valgus with a site in France, this one is the 4th largest by planned enrollment of the 13 interventional ones that give a count, is the only one that started in 2023, is one of 13 with no phase, and was the 15th registered.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 180 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →3 of the 17 studies in Hallux Valgus with a site in France are open now, in 1 country. Each count lists the studies.
Of the 21 Hallux Valgus studies recruiting now, 10 (48%) set no upper age limit and 7 (33%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2023.
Median enrollment 74 across the 13 interventional studies, 76 across the 4 observational. Of the 12 that completed or were terminated, 2 (17%) have results posted.
3 of 17 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 2 studies filed under Hallux Valgus — fewer than ten, so there is no comparison to draw.
2 of the studies in Hallux Valgus with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06680518Clinique Saint Jean, FranceTourniquet Use in Hallux Valgus Surgery | 2026-11 |
| NCT07653828GCS Ramsay Santé pour l'Enseignement et la RechercheEvaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application | 2026-12 |
Among the 17 studies in Hallux Valgus with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients randomized with psychological intervention.
Other: Psychological support
Patients with routine care with psychological support.
An interview with the psychologist before surgery.
Impact of preoperative psychological support on pain catastrophizing
By State portion of the Spielberger State-Trait Anxiety Inventory STAI.
Time frame: at baseline
Pain evaluate of catastrophizing patients
By American Orthopaedic Foot and Ankle Society (AOFAS).
Time frame: at baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Nov 2024, 21 months after the start.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 21 months is below that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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