Effect of Acupressure on the "Yin-Tang" and "Shen-Men" Points on Pre and Postoperative Anxiety in Elective Caesarean Section: a Prospective, Single-blind, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- State Trait Anxiety Inventory (STAI) score
研究概览
简要总结
Preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta.
详细描述
Preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta.
The aim of this study is to examine the efficacy of acupressure with co-stimulation of the "Yin-Tang" and "Shen-Men" points on the reduction in pre- and postoperative anxiety in elective caesarean section.
A single-blind, randomised, controlled, single-centre study will be conducted in ASA I or II patients undergoing elective caesarean section under perispinal anaesthesia. Patients will be randomised into two groups: the ACU+ group (co-stimulation of the "Yin-Tang" and "Shen-Men" points) and the ACU- group (stimulation of two sham points). Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) score and by measuring skin conductance (Electrodermal Activity [EDA]) during three periods: period 1 (at inclusion, in the patient's hospital room on the morning of the procedure), period 2 (before arrival in the operating theatre) and period 3 (in the postoperative recovery room). True or sham acupressure will be applied using adhesive beads positioned between periods 1 and 2 and left in place until the end of period 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
In this study, the acupuncturist is a registered anaesthetist doctor (=investigator) who also holds the Acupuncture Diploma of the Medicine Faculty of Paris. After opening an opaque and sealed envelope, this acupuncturist is in charge of stimulating the true or sham points for each patient, according to the allocated group. As an anaesthetist, he is also responsible of carrying out the anaesthesia. The other care providers (anaesthetic nurses and surgeons) and the patients are blinded. Notably, the primary outcome consists of a self-administered questionnaire. Moreover, to prevent any difference or modification in care according to the results of the questionnaire, the latter is only recovered when the patient leaves the postoperative recovery room. The randomisation list was created with EXCEL software. Finally, an independent person is in charge of the statistical analysis.
Considering the above, we describe the study as "single-blind".
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •informed consent obtained
- •adult patients
- •ASA class I or II
- •scheduled caesarean section at CHRU Tours Maternity
- •under perispinal anaesthesia (spinal anaesthesia or spinal and epidural anaesthesia combined)
排除标准
- •higher or equal to ASA class III
- •heart rhythm disorder
- •treated with a psychotropic drug (anxiolytic, sedative, antidepressant, antipsychotic, mood stabilizer)
- •psychiatric history
- •drug or alcohol abuse
- •local contraindications to acupuncture (local signs of infection or inflammation, scars)
- •scheduled to caesarean section under general anaesthesia.
- •Patients will be excluded in the event of transition to general anaesthesia or cancellation of the procedure.
结局指标
主要结局
State Trait Anxiety Inventory (STAI) score
时间窗: In the postoperative recovery room (this event takes place from 40 minutes to 16 hours after the inclusion, depending on the availability fo the surgeons to start the C-section and the duration of this one)
Difference between the two groups (ACU+ versus ACU-) in STAI score
次要结局
- Electrodermal Activity (EDA)(In the postoperative recovery room (this event takes place from 40 minutes to 16 hours after the inclusion, depending on the availability fo the surgeons to start the C-section and the duration of this one))