Clinical Trial

The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures

Study acronym: Respi-IR
Recruiting
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Summary
The goal of this clinical trial is to demonstrate the non-inferiority of standardized breathing control exercises on perceived pain during rheumatological injections procedures compared to standard care consisting of the addition of a local anesthetic. The study population will consist of patients scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection. The main question it aims to answer is: * Non-inferiority of breathing exercises compared to the addition of local anesthetic on pain and anxiety experienced during an infiltration procedure. * Correlation between the reduction in pain and anxiety experienced during a procedure and the cardiac coherence score obtained. Researchers will compare the anesthesia group (Arm A), which will receive local anesthesia with 5 cc of lidocaine before the infiltration procedure to the breathing group (Arm B), which will receive instructions before the injection procedure on how to perform 5-minute breathing cycles to facilitate the achievement of cardiac coherence to see if the pain perceived in Arm B is not greater than the pain perceived in Arm A. Participants will be kept blind to their randomization group. Arm A (anesthesia) will receive SHAM breathing exercises, while Arm B (breathing) will receive a placebo injection of anesthetic.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-08.
Status change: Not Yet Recruiting → Recruiting 2025-12-30
Trial Details
NCT Number NCT07172984
Lead Sponsor Centre Hospitalier Metropole Savoie
Collaborators: Université Savoie Mont Blanc
Conditions Rheumatological Injection, Pain Management, Respiratory Monitoring
Enrollment 136 participants
Start Date 2025-09-19
Primary Completion 2028-09-20 (estimated)
Study Completion 2028-09-20 (estimated)
Updated on ClinicalTrials.gov 2026-01-05