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 (ACUCESAR)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Cesarean Section; Preoperative Anxiety
• Intervention / Treatment: Device: ACUPRESSURE

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • university hospital Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Marc LAFFON, MD,PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): March 8, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Acupressure; STAI (State Trait Anxiety Inventory); EDA (Electrodermal Activity)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ACUCESAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No