Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation on SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- LF/HF ratio variation compared between the groups
研究概览
简要总结
Anxiety is a natural response to stress which peaks just before the surgery procedure. High levels of anxiety can increase postoperative pain and complications. Medicated anxiolysis is no longer recommended, in the absence of proven efficacy. Other interventions to prevent anxiety are required.
The autonomic nervous system (ANS), both sympathetic and parasympathetic, determines the response to stress. Anxiety interventions such as hypnosis, massage and relaxation work by modulating ANS tone. The ANS also modulates heart rate.
Anxiety can be measured by RR space, from which HRV, high-frequency (HF) and low-frequency (LF) are components respectively linked to the parasympathetic and sympathetic systems. The LF/HF ratio reflects sympathetic dominance if high, and parasympathetic dominance if low.
Cutaneous resonance stimulation (RESC) is a manual technique. RESC can diagnose and correct energy imbalances by skin stimulation between two points and thus act on anxiety.
We hypothesized that a preoperative RESC session would modify the sympathetic/parasympathetic balance and reduce anxiety in patients admitted for cardiac surgery, compared to patient receiving a sham RESC session: non-specific cutaneous stimulation (NSCS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Planned cardiac surgery with extracorporeal circulation
- •Pre operatory anxiety : STAI-E score >30 or Visual Analogue Scale Anxiety >6
排除标准
- •Urgent surgery
- •Atrial fibrillation
- •Impossibility to answer to STAI-E or VAS
- •Use of alternative method
- •Use of an alternative method other for anxiety before inclusion
- •Absence of consent
- •Pregnant, breastfeeding women.
结局指标
主要结局
LF/HF ratio variation compared between the groups
时间窗: Between the beginning and the end of the RESC/NCS session (20 minutes)
LF and HF will be monitored during the all RESC/NSCS.
次要结局
- Skin conductance variation compared between the groups(Between the beginning and the end of the RESC/NCS session (20 minutes))
- Perfusion index variations compared between the groups.(Between the beginning and the end of the RESC/NCS session (20 minutes))
- Morphine use post-surgery compared between the groups(Day 1)
- Heart rate variations compared between the groups.(Between the beginning and the end of the RESC/NCS session (20 minutes))
- Blood pressure variations compared between the groups.(Between the beginning and the end of the RESC/NCS session (20 minutes))
- Respiratory rate variations compared between the groups.(Between the beginning and the end of the RESC/NCS session (20 minutes))
- Analgesia nociception index compared between the groups(Between the beginning and the end of the RESC/NCS session (20 minutes))
- Anxiety compared between the groups(After de RESC/NCS session)