Preoperative Auricular Acupuncture in Elective Cesarean Section.

Not Applicable

Completed

• 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®).; Device: Apply a device having no real effect; Procedure: Disinfection

• Registration Number: NCT02707705
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Status Verified: 2017-10
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
: Auricular Acupuncture (needle patch) group A	Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®).	Needle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape.
: Auricular Acupuncture (needle patch) group A	Disinfection	Needle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape.
Needle-free patch: group P.	Apply a device having no real effect	Patients who received the auricular acupuncture protocol with adhesive tape without needles.
Needle-free patch: group P.	Disinfection	Patients who received the auricular acupuncture protocol with adhesive tape without needles.

Primary Outcome Measures

Name	Time	Method
Comparison of anxiety variation between group A (Auricular acupuncture, needle patch) and group P (needle-free patch) via visual analog scale.	measured at the inclusion (T0) and 30min/1h after inclusion (T1).	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).

Secondary Outcome Measures

Name	Time	Method
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).	Variation of anxiety VAS between T0 and T1 between the 3 groups (needle patch, needle-free patch and no intervention.; Comparing the percentage of patients relieved by auricular acupuncture between the 3 groups (decrease of anxiety VAS score of at least 20%).
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).	Variation of ANI between T0 and T1, comparison between the 3 groups. ANI is a 0 to 100 index derived from heart rate variability which provides a continuous measurement of the parasympathetic tone.
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).	Variation of APAIS between T0 and T1, comparison between the 3 groups. APAIS is a self-reported questionnaire comprising six questions.
Study of the correlation between ANI and anxiety VAS.	measured at the inclusion (T0) and 30min/1h after inclusion (T1).	Variation of ANI between T0 and T1, comparison between the 3 groups, and correlation with anxiety VAS. ANI is a 0 to 100 index derived from heart rate variability which provides a continuous measurement of the parasympathetic tone.
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).	VAS for pain is a self-reported measure varying from, 0 (no pain) to 100 (greatest possible level of pain). A comparison of VAS score will be made between the 3 groups.
Report of potential adverse events of auricular acupuncture.	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).	collection of potential side effects.
Correlation between APAIS and anxiety VAS.	Measured at the inclusion (T0) and 30min/1h after inclusion (T1).	Variation of APAIS between T0 and T1, comparison between the 3 groups, and correlation with anxiety VAS. APAIS is a self-reported questionnaire comprising six questions.

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France