RecruitingNot ApplicableNCT07172984

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

The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study


Sponsor

Centre Hospitalier Metropole Savoie

Enrollment

136 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
  • Patient able to sign an informed consent form to participate in the study

Exclusion Criteria4

  • Patient able to sign an informed consent form to participate in the study - - Allergy to the injection product or anesthetic.
  • Injection not allowing the use of a local anesthetic due to insufficient joint volume (e.g., fingers/toes).
  • Epidural injection via the sacrococcygeal hiatus.
  • Pregnant women

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Interventions

PROCEDUREAnesthesia

Receives local anesthesia with 5 cc of lidocaine before the infiltration procedure.The patient will receive breathing instructions as part of "SHAM" treatment, which will not allow them to achieve cardiac coherence.

PROCEDUREbreathing group

The procedure will use 5 cc of saline solution instead of the usual anesthesia. Explanations for performing 5-minute breathing cycles that facilitate the achievement of cardiac coherence, with visual feedback.


Locations(1)

Centre Hospitalier Métropole Savoie

Chambéry, France

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NCT07172984


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