Actively Recruiting
The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study
Led by Centre Hospitalier Metropole Savoie · Updated on 2026-01-05
136
Participants Needed
1
Research Sites
N/A
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
This research aims to evaluate whether standardized breathing control exercises can reduce pain and anxiety during rheumatological joint or periarticular injections as effectively as local anesthesia with lidocaine. The study focuses on patients scheduled for therapeutic ultrasound-guided injections and explores the relationship between pain, anxiety, and cardiac coherence during the procedure. It is a randomized, single-blind, controlled, non-inferiority clinical trial assessing alternative pain management methods. Participants will be randomly assigned to one of two groups. The anesthesia group will receive 5 cc of lidocaine before the injection along with sham breathing instructions that do not promote cardiac coherence. The breathing group will perform 5-minute breathing exercises designed to achieve cardiac coherence before receiving a saline placebo injection instead of anesthesia. Continuous heart rate monitoring will be conducted during the procedure using the EmWave PRO device to measure cardiac coherence. Throughout the study, participants will be monitored for pain, anxiety, and satisfaction using the EVA scale immediately after infiltration. The study involves continuous heart rate recording during the injection to assess the correlation between cardiac coherence and pain or anxiety levels. The trial spans from the initial procedure through post-injection assessments, aiming to provide insights into non-pharmacological pain control methods during rheumatological injections.
CONDITIONS
Brief Title
The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures
Who Can Participate
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure visit
Participants undergo a rheumatological injection procedure with either local anesthesia and breathing instructions as a sham treatment, or perform 5-minute breathing exercises with saline solution instead of anesthesia. Continuous heart rate recording is performed during the procedure.
1 visit (in-person)
Duration - Same day as injection procedure
After the injection procedure, participants' pain, anxiety, and satisfaction are assessed using the EVA scale.
1 follow-up assessment (in-person)
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Métropole Savoie
Chambéry, France, 73000
Actively Recruiting
Research Team
L
leo blervaque
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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