Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACUPLUS | Experimental | ACU+ : patients receives stimulation on the true experimental points (Yin-Tang + Shen-Men) |
|
| ACUMOINS | Placebo Comparator | ACU- : patients receives stimulation on placebo points ("sham" point) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUPRESSURE | Device | Acupressure using disposable devices consisting of a metal microbead and an adhesive material. |
|
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded in the event of transition to general anaesthesia or cancellation of the procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc LAFFON, MD,PhD | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tours | Tours | 37044 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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".
| 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) |
| ID | Term |
|---|---|
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided