Preoperative Auricular Acupuncture in Elective Cesarean Section. (CESAUR)

Civil Hospices of Lyon

Status: Completed

Conditions: Anxiety Reduction, Elective Cesarean Section

Treatments: Device: Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®).; Device: Apply a device having no real effect; Procedure: Disinfection

Study type: Interventional

Funder types: Other

Identifiers

NCT02707705

69HCL15_0352

Details and patient eligibility

About

Preoperative anxiety before cesarean section is common and may be severe. Stress consequences are often deleterious for the mother and for the upcoming newborn. Means to reduce anxiety before cesarean section are limited. Anxiolytic drugs are avoided in the context of the birth of a newborn. Auricular acupuncture has been shown to relieve anxiety disorders. The aim of this study is to evaluate the anxiolytic effect of auricular acupuncture administered before an elective cesarean section. Anxiety will be measured at T0: inclusion (approximately 1-2 hours before cesarean section) and T1: departure to surgical unit (approximately 30 minutes to 1 hour after T0). Patches (needle or needle-free) will be set up at T0 just after the initial anxiety assessment (anxiety Visual Analog Scale aVAS).

Enrollment: 91 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All patients American Society of Anaesthesiologists 1or 2 targeted for elective cesarean section under spinal anesthesia
• Aged over 18 years
• Affiliation to social security
• Participation Consent signed after oral and written information

Exclusion criteria

• Guardianship
• Psychological disorders preventing informed consent
• Long-term antidepressant or anxiolytic
• Previous history of auricular acupuncture
• Refusal of participation in the study
• Cesarean section for placenta accreta
• Presence of a pacemaker

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 3 patient groups, including a placebo group

: Auricular Acupuncture (needle patch) group A

Experimental group

Description:

Needle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape.

Treatment:

Procedure: Disinfection

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

Needle-free patch: group P.

Placebo Comparator group

Description:

Patients who received the auricular acupuncture protocol with adhesive tape without needles.

Treatment:

Procedure: Disinfection

Device: Apply a device having no real effect

No intervention: group C

No Intervention group

Description:

Patients without any device or intervention.