Clinical trial NCT06119971: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Pregnancy
Preoperative Anxiety
Keywords: Acupressure
STAI (State Trait Anxiety Inventory)
EDA (Electrodermal Activity)
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: State Trait Anxiety Inventory (STAI) score
timeFrame: At inclusion (the inclusion takes place on the morning of the surgery)
measure: State Trait Anxiety Inventory (STAI) score
timeFrame: 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)
measure: State Trait Anxiety Inventory (STAI) score
timeFrame: 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 outcomes:
measure: Electrodermal Activity (EDA)
timeFrame: At inclusion
measure: Electrodermal Activity (EDA)
timeFrame: 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)
measure: Electrodermal Activity (EDA)
timeFrame: 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)
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital Tours
Study officials:
affiliation: University Hospital, Tours
name: Marc LAFFON, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: