Centre Hospitalier Métropole Savoie
Chambéry, 73000, France
Location status: Recruiting
NCT Number: NCT07172984
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chambéry, 73000, France
Location status: Recruiting
This randomized, controlled, single-blind, single-center non-inferiority study aims to evaluate the impact of local anesthesia and breathing exercises on pain and anxiety management during joint or periarticular injections. Participants are patients referred to a rheumatology consultation or referred by an outside physician for injections requiring local anesthesia, such as those performed on the shoulder, elbow, knee, hip, or ankle.
Patients will be kept blind to their randomization group. In both groups, continuous heart rate recording will be performed during the procedure using the EmWave PRO device (to assess cardiorespiratory variability and calculate a cardiac coherence score).
In the "anesthesia" group, local anesthesia with 5 cc of lidocaine will be administered before the infiltration procedure, and the patient will receive breathing instructions as part of "SHAM" management, which will prevent them from achieving cardiac coherence.
In the "breathing" group, patients will perform 5-minute breathing exercises before the procedure (10-second cycles: 5 seconds of inhalation and 5 seconds of exhalation) to enable them to achieve the expected analgesic cardiac coherence. The practitioner performing the procedure will use 5 cc of saline solution instead of the usual anesthesia.
After infiltration, participants' pain, anxiety, and satisfaction will be measured using EVA scale.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receives 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.
The 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.
Time frame: during 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 the 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 procedure
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: end of intervention
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.
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Metropole Savoie
Other
The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study
Acronym: Respi-IR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07695987
Agnosia, Nervous System Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07716540
Agnosia, Nervous System Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07226700
Agnosia, JOURNAVX
New York, United States
View Trial DetailsNCT07707609
Agnosia, Chronic Disease
Hyderabad, Telangana, India
View Trial Details