Clinical trial NCT02707705: Preoperative Auricular Acupuncture in Elective Cesarean Section.
Official title: Premedication With an Auricular Acupuncture Protocol in Elective Cesarean Section .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Reduction, Elective Cesarean Section
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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

Primary outcomes:
measure: Comparison of anxiety variation between group A (Auricular acupuncture, needle patch) and group P (needle-free patch) via visual analog scale.
timeFrame: measured at the inclusion (T0) and 30min/1h after inclusion (T1).
Secondary outcomes:
measure: Potential placebo effect of auricular acupuncture by measuring Anxiety variation between the 3 groups.
timeFrame: 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).
measure: To evaluate anxiolytic effect of auricular acupuncture on anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS).
timeFrame: measured at the inclusion (T0) and 30min/1h after inclusion (T1).
measure: To evaluate the effect of auricular acupuncture on parasympathetic tone measured by Analgesia Nociception Index (ANI).
timeFrame: measured at the inclusion (T0) and 30min/1h after inclusion (T1).
measure: Study of the correlation between ANI and anxiety VAS.
timeFrame: measured at the inclusion (T0) and 30min/1h after inclusion (T1).
measure: To evaluate the effect of auricular acupuncture on perioperative pain.
timeFrame: Measured at1h/2h after inclusion (incision T2) and 3h/4h after inclusion (back in post-operative surveillance room T3).
measure: Report of potential adverse events of auricular acupuncture.
timeFrame: Measured at 30min/1h after inclusion (T1), 1h/2h after inclusion (incision T2) and 3h/4h after inclusion (back in post-operative surveillance room T3).
measure: Correlation between APAIS and anxiety VAS.
timeFrame: Measured at the inclusion (T0) and 30min/1h after inclusion (T1).
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
References: