- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02707705
Preoperative Auricular Acupuncture in Elective Cesarean Section. (CESAUR)
Premedication With an Auricular Acupuncture Protocol in Elective Cesarean Section .
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69317
- Hopital de la Croix Rousse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: : Auricular Acupuncture (needle patch) group A
Needle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape.
|
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 :
The ear is disinfected by applying Chlorhexidine®.
|
Placebo Comparator: Needle-free patch: group P.
Patients who received the auricular acupuncture protocol with adhesive tape without needles.
|
The ear is disinfected by applying Chlorhexidine®.
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 :
|
No Intervention: No intervention: group C
Patients without any device or intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of anxiety variation between group A (Auricular acupuncture, needle patch) and group P (needle-free patch) via visual analog scale.
Time Frame: 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).
|
measured at the inclusion (T0) and 30min/1h after inclusion (T1).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Potential placebo effect of auricular acupuncture by measuring Anxiety variation between the 3 groups.
Time Frame: 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%). |
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).
Time Frame: 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.
|
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).
Time Frame: 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.
|
measured at the inclusion (T0) and 30min/1h after inclusion (T1).
|
Study of the correlation between ANI and anxiety VAS.
Time Frame: 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.
|
measured at the inclusion (T0) and 30min/1h after inclusion (T1).
|
To evaluate the effect of auricular acupuncture on perioperative pain.
Time Frame: 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.
|
Measured at1h/2h after inclusion (incision T2) and 3h/4h after inclusion (back in post-operative surveillance room T3).
|
Report of potential adverse events of auricular acupuncture.
Time Frame: 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.
|
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).
|
Correlation between APAIS and anxiety VAS.
Time Frame: 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.
|
Measured at the inclusion (T0) and 30min/1h after inclusion (T1).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL15_0352
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety Reduction, Elective Cesarean Section
-
University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaCompletedElective Cesarean SectionCanada
-
Stony Brook UniversityRecruitingElective Cesarean SectionUnited States
-
Xuzhou Medical UniversityCompletedSpinal Anesthesia | Elective Cesarean SectionChina
-
Xuzhou Medical UniversityCompletedSpinal Anesthesia | Elective Cesarean SectionChina
-
University Hospital PadovaCompletedElective Cesarean Section | Umbilical Cord ManagementItaly
-
Université de SherbrookeCompletedElective Cesarean Section | Term Birth (Pregnancy)Canada
-
Pacira Pharmaceuticals, IncCompletedPain Management | Elective Cesarean SectionUnited States
-
Medical University of ViennaCompleted
-
Ain Shams UniversityUnknownThe Effect of Early Versus Traditional Hospital Discharge for Women Undergoing Elective Cesarean SectionEgypt
-
Sheba Medical CenterTerminatedElective Cesarean Section | Maternal Hypotention