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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06119971
Other study ID # ACUCESAR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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