Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07172984

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

Led by Centre Hospitalier Metropole Savoie · Updated on 2026-01-05

136

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Metropole Savoie

Lead Sponsor

U

Université Savoie Mont Blanc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
  • Patient able to sign an informed consent form to participate in the study
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier Métropole Savoie

Chambéry, France, 73000

Actively Recruiting

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Research Team

L

leo blervaque

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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