The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures

NCT07172984 | Recruiting

• 2 other identifiers: CHMS250012025-A00019-40
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatological Injection; Pain Management; Respiratory Monitoring

Keywords

rheumatological injection; local anesthesia during intra-articular injection; respiratory rate monitoring

Outcome Measures

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.

  during injection

Secondary Outcomes (3)

• anxiety during procedure

  during the procedure

• Cardiac coherence score

  during procedure

• pain correlated with cardiac coherence score

  end of intervention

Study Arms (2)

Anesthesia group

ACTIVE COMPARATOR

Receives local anesthesia with 5 cc of lidocaine before the infiltration procedure.

Procedure: Anesthesia

breathing group

EXPERIMENTAL

Explanations for performing 5-minute breathing cycles that facilitate the achievement of cardiac coherence, with visual feedback.

Procedure: breathing group

Interventions

Anesthesia PROCEDURE

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.

Anesthesia group

breathing group PROCEDURE

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.

breathing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead
• Université Savoie Mont Blanc: collaborator

Study Sites (1)

Centre Hospitalier Métropole Savoie

Chambéry, 73000, France

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

leo blervaque

CONTACT

+33 4 79 96 58 13; urc@ch-metropole-savoie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): September 20, 2028
• Study Completion (Estimated): September 20, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)