The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Metropole Savoie
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
Patient able to sign an informed consent form to participate in the study
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Anesthesia
Procedure/SurgeryReceives 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.
breathing group
Procedure/SurgeryThe 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.
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: Anesthesia groupActive comparator 1 intervention
Group B: breathing groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain during rheumatological injection
Pain perceived during rheumatological injection measured using the Visual Analog Scale between 0 to 10 (the higher score mean the worst outcome) and compared between groups.
Time frame
during injectionSecondary outcomes
1
anxiety during procedure
Anxiety experienced during the procedure, measured by the Visual Analog Scale between 0 to 10, the higher score mean the worst outcome and compared between groups.
Time frame
during the procedure2
Cardiac coherence score
Cardiac coherence score during injection (0 to 100, the higher score mean the better outcome) , provided by the EMWAVE device, compared between the breathing group and the anesthesia group.
Time frame
during procedure3
pain correlated with cardiac coherence score
Pain measured using the Visual Analog Scale ( 0 to 10, the higher score mean the worst outcome) , correlated within the experimental group with the cardiac coherence score.
Time frame
end of interventionSponsors and contacts
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Centre Hospitalier Metropole Savoie
Lead sponsor
Université Savoie Mont Blanc
Collaborator
Source ClinicalTrials.gov