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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Cesarean Section, Pregnancy, Preoperative Anxiety

Intervention / Treatment
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* Device: ACUPRESSURE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACUPLUS<br>ACU+ : patients receives stimulation on the true experimental points (Yin-Tang + Shen-Men) | Device: ACUPRESSURE<br>* Acupressure using disposable devices consisting of a metal microbead and an adhesive material.<br>|
| Placebo Comparator: ACUMOINS<br>ACU- : patients receives stimulation on placebo points (sham point) | Device: ACUPRESSURE<br>* Acupressure using disposable devices consisting of a metal microbead and an adhesive material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State Trait Anxiety Inventory (STAI) score | Difference between the two groups (ACU+ versus ACU-) in STAI score | At inclusion (the inclusion takes place on the morning of the surgery) | 
| State Trait Anxiety Inventory (STAI) score | Difference between the two groups (ACU+ versus ACU-) in STAI score | At the entrance in the operative room (this event takes place from 20 minutes to 12 hours after the inclusion, depending on the availability of the surgeons to start the C-section) | 
| State Trait Anxiety Inventory (STAI) score | Difference between the two groups (ACU+ versus ACU-) in 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrodermal Activity (EDA) | Difference between the two groups (ACU+ versus ACU-) in EDA | At inclusion | 
| Electrodermal Activity (EDA) | Difference between the two groups (ACU+ versus ACU-) in EDA | At the entrance in the operative room (this event takes place from 20 minutes to 12 hours after the inclusion, depending on the availability of the surgeons to start the C-section) | 
| Electrodermal Activity (EDA) | Difference between the two groups (ACU+ versus ACU-) in 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupressure, STAI (State Trait Anxiety Inventory), EDA (Electrodermal Activity)