Anxiety Reduction, Elective Cesarean SectionCESAURNCT02707705
Preoperative Auricular Acupuncture in Elective Cesarean Section.
A study testing Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®)., Apply a device having no real effect and Disinfection in people with Anxiety Reduction, Elective Cesarean Section, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Reduction, Elective Cesarean Section
- What is being tested?
- Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®)., Apply a device having no real effect and Disinfection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Premedication With an Auricular Acupuncture Protocol in Elective Cesarean Section .
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).
- Being tested
- Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®)., Apply a device having no real effect, Disinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®).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
Apply a device having no real effectDevice
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
DisinfectionProcedure or surgery
The ear is disinfected by applying Chlorhexidine®.
| Study group | Role | What they receive |
|---|---|---|
| : Auricular Acupuncture (needle patch) group A | Experimental | Needle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape. Receives: Device: Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®).; Procedure: Disinfection |
| Needle-free patch: group P. | Placebo comparator | Patients who received the auricular acupuncture protocol with adhesive tape without needles. Receives: Device: Apply a device having no real effect; Procedure: Disinfection |
| No intervention: group C | No intervention | Patients without any device or intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
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: 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).
Variation of APAIS between T0 and T1, comparison between the 3 groups. APAIS is a self-reported questionnaire comprising six questions.
Measured: 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).
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: measured at the inclusion (T0) and 30min/1h after inclusion (T1).
Study of the correlation between ANI and anxiety VAS.
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: measured at the inclusion (T0) and 30min/1h after inclusion (T1).
To evaluate the effect of auricular acupuncture on perioperative pain.
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: 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.
collection of potential side effects.
Measured: 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.
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: Measured at the inclusion (T0) and 30min/1h after inclusion (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety Reduction, Elective Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707705
- Sponsor's protocol ID
- 69HCL15_0352
- Acronym
- CESAUR
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2016
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35394895
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication With an Auricular Acupuncture Protocol in Elective Cesarean Section .
- ClinicalTrials.gov ID
- NCT02707705
- Acronym / sponsor ID
- CESAUR / 69HCL15_0352
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| : Auricular Acupuncture (needle patch) group A | Experimental | Device: Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®)., Procedure: DisinfectionNeedle patch: Patients receiving the auricular acupuncture protocol with needles inserted on adhesive tape. |
| Needle-free patch: group P. | Placebo comparator | Device: Apply a device having no real effect, Procedure: DisinfectionPatients who received the auricular acupuncture protocol with adhesive tape without needles. |
| No intervention: group C | No intervention | –Patients without any device or intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Guardianship
- Psychological disorders preventing informed consent
- Long-term antidepressant or anxiolytic
- Previous history of auricular acupuncture
- Refusal of participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | : Auricular Acupuncture (needle patch) group A |
| Apply a device having no real effectThe 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 | Device | Needle-free patch: group P. |
| DisinfectionThe ear is disinfected by applying Chlorhexidine®. | Procedure or surgery | : Auricular Acupuncture (needle patch) group A, Needle-free patch: group P. |
Primary outcome
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).
7 secondary outcomes
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).
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).
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).
Study of the correlation between ANI and anxiety VAS.
Time frame: 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).
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).
Correlation between APAIS and anxiety VAS.
Time frame: Measured at the inclusion (T0) and 30min/1h after inclusion (T1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 35394895Favre-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®)., Apply a device having no real effect and Disinfection in people with Anxiety Reduction, Elective Cesarean Section, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.