NCT07172984 The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures
| NCT ID | NCT07172984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Metropole Savoie |
| Condition | Rheumatological Injection |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2028-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2025-09-19 with a primary completion date of 2028-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07172984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatological Injection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07172984 currently recruiting?
Yes, NCT07172984 is actively recruiting participants. Contact the research team at urc@ch-metropole-savoie.fr for enrollment information.
Where is the NCT07172984 trial being conducted?
This trial is being conducted at Chambéry, France.
Who is sponsoring the NCT07172984 clinical trial?
NCT07172984 is sponsored by Centre Hospitalier Metropole Savoie. The trial plans to enroll 136 participants.