Standardized breathing control during rheumatological injections
The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study
This trial will try whether a 5-minute guided breathing exercise can reduce pain and anxiety during ultrasound-guided joint or periarticular injections for people having rheumatological injections, compared with local lidocaine anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Metropole Savoie Academic / other |
| Locations | 1 site (Chambéry) |
| Trial ID | NCT07172984 on ClinicalTrials.gov |
What this trial studies
This is a randomized, single-blind, single-center non-inferiority trial comparing two approaches to managing pain and anxiety during therapeutic ultrasound-guided joint or periarticular injections. One group receives 5 cc of lidocaine before the injection plus sham breathing instructions, while the other group performs a 5-minute paced breathing exercise and receives saline instead of lidocaine. Continuous heart rate recording with the EmWave PRO device will measure cardiorespiratory variability and a cardiac coherence score during the procedure. Pain, anxiety, and patient satisfaction will be measured after infiltration using EVA scales.
Who should consider this trial
Good fit: Adults scheduled for therapeutic ultrasound-guided joint or periarticular injections who can give informed consent and follow breathing instructions are the ideal candidates.
Not a fit: Patients having injections in sites with insufficient joint volume (for example fingers or toes), those allergic to the anesthetic, pregnant women, or people unable to perform paced breathing may not receive benefit from the breathing approach.
Why it matters
Potential benefit: If successful, guided breathing could offer a low-cost, drug-free way to reduce pain and anxiety during joint injections and reduce reliance on local anesthetic.
How similar studies have performed: Some prior work shows paced breathing and cardiac coherence can reduce pain and anxiety in medical settings, but substituting breathing for local anesthesia in joint injections is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chambéry
- Centre Hospitalier Métropole Savoie — Chambéry, France (Recruiting)
Study contacts
- Study coordinator: leo blervaque
- Email: urc@ch-metropole-savoie.fr
- Phone: +33 4 79 96 58 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.