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
- Conditions
- PregnancyPreoperative AnxietyCesarean Section
- Interventions
- Device: ACUPRESSURE
- Registration Number
- NCT06119971
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACUPLUS ACUPRESSURE ACU+ : patients receives stimulation on the true experimental points (Yin-Tang + Shen-Men) ACUMOINS ACUPRESSURE ACU- : patients receives stimulation on placebo points ("sham" point)
- Primary Outcome Measures
Name Time Method State Trait Anxiety Inventory (STAI) score 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
- Secondary Outcome Measures
Name Time Method 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) Difference between the two groups (ACU+ versus ACU-) in EDA
Trial Locations
- Locations (1)
University Hospital Tours
🇫🇷Tours, France