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