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Preoperative Auricular Acupuncture in Elective Cesarean Section.

NCT02707705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-09-18

No results posted yet for this study

Summary

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).

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®.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02707705 on ClinicalTrials.gov