Assessment of the Benefits of Psychological Care Before Anterior Cruciate Ligament Surgery of the Knee (CLIPPER)

NCT07671430 | Recruiting

• 1 other identifier: COS-RGDS-2025-06-040-P-HARDY-A
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Ligament Reconstruction Surgery

Outcome Measures

Primary Outcomes (1)

• 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)

  First night following surgery

Study Arms (2)

Standard care (based on consultations with the surgeon and anesthesiologist)

NO INTERVENTION

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

Behavioral: A consultation with a psychologist prior to surgery

Interventions

A consultation with a psychologist prior to surgery BEHAVIORAL

A videoconference consultation with a psychologist prior to surgery

Standard care supplemented by the involvement of a psychologist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

clinique du Sport

Paris, 75005, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)