Preoperative Auricular Acupuncture in Elective Cesarean Section.

NACompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

February 28, 2018

Study Completion Date

February 28, 2018

Conditions
Anxiety Reduction, Elective Cesarean Section
Interventions
DEVICE

Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®).

"Intervention Description :~The auricular acupuncture protocol is based on an anxiolytic triad of three points selected according to the World Health Organization classification. These points are detected and located precisely by a differential detector starting with the right ear, and in the absence of response, the points are searched on the left ear. The detected points are treated by application of adhesive tape with needles of diameter 0.2 mm and length 0.9 mm.~Data collected :~* T0 : anxiety VAS, pain VAS, APAIS, ANI, arterial pressure and cardiac frequency~* T1 : anxiety VAS, pain VAS, APAIS, ANI, arterial pressure, cardiac frequency and side effects~* T2 : anxiety VAS, pain VAS, arterial pressure, cardiac frequency and side effects~* T3 : anxiety VAS, pain VAS, arterial pressure, cardiac frequency and side effects"

DEVICE

Apply a device having no real effect

"The three points of the protocol are detected and located precisely by a differential detector starting with the right ear, and in the absence of response, the points are searched on the left ear.The detected points are treated by application of adhesive tape without needle.~Data collected :~* T0 : anxiety VAS, pain VAS, APAIS, ANI, arterial pressure and cardiac frequency~* T1 : anxiety VAS, pain VAS, APAIS, ANI, arterial pressure, cardiac frequency and side effects~* T2 : anxiety VAS, pain VAS, arterial pressure, cardiac frequency and side effects~* T3 : anxiety VAS, pain VAS, arterial pressure, cardiac frequency and side effects"

PROCEDURE

Disinfection

The ear is disinfected by applying Chlorhexidine®.

Trial Locations (1)

69317

Hôpital de la Croix Rousse, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02707705 - Preoperative Auricular Acupuncture in Elective Cesarean Section. | Biotech Hunter | Biotech Hunter