Preoperative Auricular Acupuncture in Elective Cesarean Section.
CESAUR
Premedication With an Auricular Acupuncture Protocol in Elective Cesarean Section .
1 other identifier
interventional
91
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedSeptember 18, 2025
September 1, 2025
2 years
February 23, 2016
September 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of anxiety variation between group A (Auricular acupuncture, needle patch) and group P (needle-free patch) via visual analog scale.
Degree of reduction in anxiety VAS score between T0 and T1 and comparison between group A and group P. Anxiety will be assessed using a Visual Analogue Scale scoring between 0 (complete absence of anxiety) and 100 (greatest possible level of anxiety).
measured at the inclusion (T0) and 30min/1h after inclusion (T1).
Secondary Outcomes (7)
Potential placebo effect of auricular acupuncture by measuring Anxiety variation between the 3 groups.
measured at the inclusion (T0), 30min/1h after inclusion (T1), 1h/2h after inclusion (incision T2) and 3h/4h after inclusion (back in post-operative surveillance room T3).
To evaluate anxiolytic effect of auricular acupuncture on anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS).
measured at the inclusion (T0) and 30min/1h after inclusion (T1).
To evaluate the effect of auricular acupuncture on parasympathetic tone measured by Analgesia Nociception Index (ANI).
measured at the inclusion (T0) and 30min/1h after inclusion (T1).
Study of the correlation between ANI and anxiety VAS.
measured at the inclusion (T0) and 30min/1h after inclusion (T1).
To evaluate the effect of auricular acupuncture on perioperative pain.
Measured at1h/2h after inclusion (incision T2) and 3h/4h after inclusion (back in post-operative surveillance room T3).
- +2 more secondary outcomes
Study Arms (3)
: Auricular Acupuncture (needle patch) group A
EXPERIMENTALNeedle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape.
Needle-free patch: group P.
PLACEBO COMPARATORPatients who received the auricular acupuncture protocol with adhesive tape without needles.
No intervention: group C
NO INTERVENTIONPatients without any device or intervention.
Interventions
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
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
The ear is disinfected by applying Chlorhexidine®.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital de la Croix Rousse
Lyon, 69317, France
Related Publications (1)
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.
PMID: 35394895RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2016
First Posted
March 14, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
September 18, 2025
Record last verified: 2025-09