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临床试验/NCT07172984
NCT07172984招募中不适用

The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Infiltration Procedures - A Single-blind, Randomized, Controlled Non-inferiority Study

Centre Hospitalier Metropole Savoie1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年9月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
136
试验地点
1
主要终点
Pain during rheumatological injection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.
  • Patient able to sign an informed consent form to participate in the study

排除标准

  • 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

结局指标

主要结局

Pain during rheumatological injection

时间窗: 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.

Pain during rheumatological injection

时间窗: 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.

次要结局

  • anxiety during procedure(during the procedure)
  • Cardiac coherence score(during procedure)
  • pain correlated with cardiac coherence score(end of intervention)
  • anxiety during procedure(during the procedure)
  • Cardiac coherence score(during procedure)
  • pain correlated with cardiac coherence score(end of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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