AnxietyCLIPPERNCT07671430
Assessment of the Benefits of Psychological Care Before Anterior Cruciate Ligament Surgery of the Knee (CLIPPER)
A study testing A consultation with a psychologist prior to surgery in people with Anxiety and Ligament Reconstruction Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The primary objective of this study is to assess the impact of a preoperative psychological consultation on postoperative pain in anxious patients undergoing primary anterior cruciate ligament reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Ligament Reconstruction Surgery
- What is being tested?
- A consultation with a psychologist prior to surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient having signed the consent form for participation in the study
- Patient scheduled for first-line outpatient ACL reconstruction surgery
- Patient with a score >30 on the SFQ questionnaire (which assesses fear of surgery)
- Patient with the ability to connect to the internet and follow a teleconsultation on a screen
Who cannot join
- Surgical history of the operated knee
- History of psychiatric disorders and/or regular use of psychotropic medication
- Regular use of opioid medication
- Mental disability or any other reason that may hinder understanding or strict adherence to the protocol
- Patient not affiliated with the French social security system
- Patient under legal protection, guardianship or curatorship
- Pregnant, breastfeeding or childbearing women without effective contraception
- A patient who is already enrolled in another therapeutic study protocol or who has participated in another trial within the past three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
clinique du Sport
Paris, 75005
HARDY Alexandre, Doctor, 01 86 86 75 05, alexandre.hardy@me.com
About this study
The primary objective of this study is to assess the impact of a preoperative psychological consultation on postoperative pain in anxious patients undergoing primary anterior cruciate ligament reconstruction surgery.
- Conditions
- Anxiety, Ligament Reconstruction Surgery
- Being tested
- A consultation with a psychologist prior to surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A consultation with a psychologist prior to surgeryBehavioural
A videoconference consultation with a psychologist prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard care (based on consultations with the surgeon and anesthesiologist) | No intervention | Not described |
| Standard care supplemented by the involvement of a psychologist | Experimental | Base on standard care supplemented with a consultation with a psychologist takes place prior to the surgery Receives: Behavioral: A consultation with a psychologist prior to surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the intensity of postoperative pain between the two groups during the night following the procedure
The maximum pain intensity experienced during the first night after surgery is measured using a numerical rating scale (NRS)
Measured: First night following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start7 May 2026
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671430
- Sponsor's protocol ID
- COS-RGDS-2025-06-040-P-HARDY-A
- Acronym
- CLIPPER
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Benefits of Psychological Care Before Anterior Cruciate Ligament Surgery of the Knee (CLIPPER)
- ClinicalTrials.gov ID
- NCT07671430
- Acronym / sponsor ID
- CLIPPER / COS-RGDS-2025-06-040-P-HARDY-A
- Conditions
- Anxiety, Ligament Reconstruction Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Jun 2026 (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.
The primary objective of this study is to assess the impact of a preoperative psychological consultation on postoperative pain in anxious patients undergoing primary anterior cruciate ligament reconstruction surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care (based on consultations with the surgeon and anesthesiologist) | No intervention | – |
| Standard care supplemented by the involvement of a psychologist | Experimental | Behavioral: A consultation with a psychologist prior to surgeryBase on standard care supplemented with a consultation with a psychologist takes place prior to the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient having signed the consent form for participation in the study
- Patient scheduled for first-line outpatient ACL reconstruction surgery
- Patient with a score >30 on the SFQ questionnaire (which assesses fear of surgery)
- Patient with the ability to connect to the internet and follow a teleconsultation on a screen
Key exclusion criteria (8 listed)
- Surgical history of the operated knee
- History of psychiatric disorders and/or regular use of psychotropic medication
- Regular use of opioid medication
- Mental disability or any other reason that may hinder understanding or strict adherence to the protocol
- Patient not affiliated with the French social security 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 |
|---|---|---|
| A consultation with a psychologist prior to surgeryA videoconference consultation with a psychologist prior to surgery | Behavioural | Standard care supplemented by the involvement of a psychologist |
Primary outcome
Compare the intensity of postoperative pain between the two groups during the night following the procedure
Time frame: First night following surgery
The maximum pain intensity experienced during the first night after surgery is measured using a numerical rating scale (NRS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A consultation with a psychologist prior to surgery in people with Anxiety and Ligament Reconstruction Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the intensity of postoperative pain between the two groups during the night following the procedure (time frame: First night following surgery). 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 26 Jun 2026.