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

Pregnancy Clinical Trial

— ACUCESAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06119971
• Other study ID #: ACUCESAR
• Status: Completed
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: March 8, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Cesarean Section
• Pregnancy
• Preoperative Anxiety

Intervention

Device:
• ACUPRESSURE
Acupressure using disposable devices consisting of a metal microbead and an adhesive material.

Locations

Country	Name	City	State
France	University Hospital Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Electrodermal Activity (EDA)	Difference between the two groups (ACU+ versus ACU-) in EDA	At inclusion
Secondary	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)
Secondary	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)