Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07172984

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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)

Follow-up

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

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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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