Cesarean Section, Pregnancy, Preoperative Anxiety
Conditions
Keywords
Acupressure, STAI (State Trait Anxiety Inventory), EDA (Electrodermal Activity)
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.
Interventions
DEVICEACUPRESSURE
Acupressure using disposable devices consisting of a metal microbead and an adhesive material.
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
In this study, the acupuncturist is a registered anaesthetist doctor (=investigator) who also holds the Acupuncture Diploma of the Medicine Faculty of Paris. After opening an opaque and sealed envelope, this acupuncturist is in charge of stimulating the true or sham points for each patient, according to the allocated group. As an anaesthetist, he is also responsible of carrying out the anaesthesia. The other care providers (anaesthetic nurses and surgeons) and the patients are blinded. Notably, the primary outcome consists of a self-administered questionnaire. Moreover, to prevent any difference or modification in care according to the results of the questionnaire, the latter is only recovered when the patient leaves the postoperative recovery room. The randomisation list was created with EXCEL software. Finally, an independent person is in charge of the statistical analysis. Considering the above, we describe the study as single-blind.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State Trait Anxiety Inventory (STAI) score | At inclusion (the inclusion takes place on the morning of the surgery) | Difference between the two groups (ACU+ versus ACU-) in STAI score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrodermal Activity (EDA) | At inclusion | Difference between the two groups (ACU+ versus ACU-) in EDA |
Countries
France
Outcome results
None listed