Hallux Valgus SurgeryPrePS HVNCT06460909
Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery
A study testing Psychological support in people with Hallux Valgus Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus Surgery
- What is being tested?
- Psychological support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2023to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult over 18
- Independent, living in its own home
- Affiliated at a social security
- Consent signed
- Waiting for a Hallux Valgus surgery.
Who cannot join
- Not Able to understand french language
- Patient refusal
- Under guardianship
- Under french AME system
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Orthopedia and traumatological department
Boulogne-Billancourt, 92100
About this study
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.
Read more
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
- Being tested
- Psychological support
- Keywords
- Hallux Valgus Surgery, Psychological Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological supportOther
An interview with the psychologist before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Psychological support arm | Experimental | Patients randomized with psychological intervention. Receives: Other: Psychological support |
| Without support | No intervention | Patients with routine care with psychological support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of preoperative psychological support on pain catastrophizing
By State portion of the Spielberger State-Trait Anxiety Inventory STAI.
Measured: at baseline
Secondary outcomes (1)
Pain evaluate of catastrophizing patients
By American Orthopaedic Foot and Ankle Society (AOFAS).
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start2 Feb 2023
- Primary completion2 Nov 2024 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Hélène Sandiford, Principal investigator, Ambroise Paré hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460909
- Sponsor's protocol ID
- APHP220331
- Other IDs
- 2022-A00381-42
- Acronym
- PrePS HV
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery
- ClinicalTrials.gov ID
- NCT06460909
- Acronym / sponsor ID
- PrePS HV / APHP220331
- Conditions
- Hallux Valgus Surgery
- Keywords
- Hallux Valgus Surgery, Psychological Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 2 Nov 2024 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological support arm | Experimental | Other: Psychological supportPatients randomized with psychological intervention. |
| Without support | No intervention | –Patients with routine care with psychological support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult over 18
- Independent, living in its own home
- Affiliated at a social security
- Consent signed
- Waiting for a Hallux Valgus surgery.
Key exclusion criteria (4 listed)
- Not Able to understand french language
- Patient refusal
- Under guardianship
- Under french AME system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological supportAn interview with the psychologist before surgery. | Other | Psychological support arm |
Primary outcome
Impact of preoperative psychological support on pain catastrophizing
Time frame: at baseline
By State portion of the Spielberger State-Trait Anxiety Inventory STAI.
1 secondary outcome
Pain evaluate of catastrophizing patients
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hallux Valgus Surgery
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
Recruiting
Evaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application
Hallux Valgus
Recruiting
Tourniquet Use in Hallux Valgus Surgery
Hallux Valgus
Recruiting
The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
Hallux Valgus, Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène Sandiford principal investigator
Ambroise Paré hospital - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological support in people with Hallux Valgus Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Hélène SANDIFORD (+33662148018, mh.sandiford@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of preoperative psychological support on pain catastrophizing (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.