Premedication With an Auricular Acupuncture Protocol in Elective Cesarean Section .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Comparison of anxiety variation between group A (Auricular acupuncture, needle patch) and group P (needle-free patch) via visual analog scale.
研究概览
简要总结
Preoperative anxiety before cesarean section is common and may be severe. Stress consequences are often deleterious for the mother and for the upcoming newborn. Means to reduce anxiety before cesarean section are limited. Anxiolytic drugs are avoided in the context of the birth of a newborn. Auricular acupuncture has been shown to relieve anxiety disorders. The aim of this study is to evaluate the anxiolytic effect of auricular acupuncture administered before an elective cesarean section. Anxiety will be measured at T0: inclusion (approximately 1-2 hours before cesarean section) and T1: departure to surgical unit (approximately 30 minutes to 1 hour after T0). Patches (needle or needle-free) will be set up at T0 just after the initial anxiety assessment (anxiety Visual Analog Scale aVAS).
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
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients American Society of Anaesthesiologists 1or 2 targeted for elective cesarean section under spinal anesthesia
- •Aged over 18 years
- •Affiliation to social security
- •Participation Consent signed after oral and written information
排除标准
- •Guardianship
- •Psychological disorders preventing informed consent
- •Long-term antidepressant or anxiolytic
- •Previous history of auricular acupuncture
- •Refusal of participation in the study
- •Cesarean section for placenta accreta
- •Presence of a pacemaker
研究组 & 干预措施
: Auricular Acupuncture (needle patch) group A
Needle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape.
干预措施: Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®). (Device)
: Auricular Acupuncture (needle patch) group A
Needle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape.
干预措施: Disinfection (Procedure)
Needle-free patch: group P.
Patients who received the auricular acupuncture protocol with adhesive tape without needles.
干预措施: Apply a device having no real effect (Device)
Needle-free patch: group P.
Patients who received the auricular acupuncture protocol with adhesive tape without needles.
干预措施: Disinfection (Procedure)
No intervention: group C
Patients without any device or intervention.
结局指标
主要结局
Comparison of anxiety variation between group A (Auricular acupuncture, needle patch) and group P (needle-free patch) via visual analog scale.
时间窗: measured at the inclusion (T0) and 30min/1h after inclusion (T1).
Degree of reduction in anxiety VAS score between T0 and T1 and comparison between group A and group P. Anxiety will be assessed using a Visual Analogue Scale scoring between 0 (complete absence of anxiety) and 100 (greatest possible level of anxiety).
次要结局
- Potential placebo effect of auricular acupuncture by measuring Anxiety variation between the 3 groups.(measured at the inclusion (T0), 30min/1h after inclusion (T1), 1h/2h after inclusion (incision T2) and 3h/4h after inclusion (back in post-operative surveillance room T3).)
- To evaluate the effect of auricular acupuncture on parasympathetic tone measured by Analgesia Nociception Index (ANI).(measured at the inclusion (T0) and 30min/1h after inclusion (T1).)
- To evaluate anxiolytic effect of auricular acupuncture on anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS).(measured at the inclusion (T0) and 30min/1h after inclusion (T1).)
- Study of the correlation between ANI and anxiety VAS.(measured at the inclusion (T0) and 30min/1h after inclusion (T1).)
- To evaluate the effect of auricular acupuncture on perioperative pain.(Measured at1h/2h after inclusion (incision T2) and 3h/4h after inclusion (back in post-operative surveillance room T3).)
- Report of potential adverse events of auricular acupuncture.(Measured at 30min/1h after inclusion (T1), 1h/2h after inclusion (incision T2) and 3h/4h after inclusion (back in post-operative surveillance room T3).)
- Correlation between APAIS and anxiety VAS.(Measured at the inclusion (T0) and 30min/1h after inclusion (T1).)