Preoperative Auricular Acupuncture in Elective Cesarean Section.

NCT ID: NCT02707705

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

: Auricular Acupuncture (needle patch) group A

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Disinfection

Intervention Type: PROCEDURE

The ear is disinfected by applying Chlorhexidine®.

Needle-free patch: group P.

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

Group Type: PLACEBO_COMPARATOR

Apply a device having no real effect

Intervention Type: DEVICE

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

Disinfection

Intervention Type: PROCEDURE

The ear is disinfected by applying Chlorhexidine®.

No intervention: group C

Patients without any device or intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Disinfection

The ear is disinfected by applying Chlorhexidine®.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital de la Croix Rousse

Lyon, , France

Countries

France

References

Favre-Felix J, Laurent V, Branche P, Huissoud C, Raffin M, Pradat P, Aubrun F, Dziadzko M. Auricular Acupuncture for Preoperative Anxiety in Parturient Women with Scheduled Cesarean Section: A Randomized Placebo-Controlled Blind Study. J Integr Complement Med. 2022 Jul;28(7):569-578. doi: 10.1089/jicm.2021.0346. Epub 2022 Apr 8.

Reference Type: RESULT

PMID: 35394895 (View on PubMed)

Other Identifiers

69HCL15_0352

Identifier Type: -

Identifier Source: org_study_id