Cesarean SectionACUCESARNCT06119971
Effect of Acupressure on the "Yin-Tang" and "Shen-Men" Points on Pre and Postoperative Anxiety in Elective Caesarean Section: a Prospective, Single-blind, Randomised, Controlled Trial
A study testing ACUPRESSURE in people with Cesarean Section and Pregnancy, run by University Hospital, Tours at 1 site in France.
Trial summary
Preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Pregnancy, Preoperative Anxiety
- What is being tested?
- ACUPRESSURE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2022to 8 Mar 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent obtained
- adult patients
- ASA class I or II
- scheduled caesarean section at CHRU Tours Maternity
- under perispinal anaesthesia (spinal anaesthesia or spinal and epidural anaesthesia combined)
Who cannot join
- higher or equal to ASA class III
- heart rhythm disorder
- treated with a psychotropic drug (anxiolytic, sedative, antidepressant, antipsychotic, mood stabilizer)
- psychiatric history
- drug or alcohol abuse
- local contraindications to acupuncture (local signs of infection or inflammation, scars)
- scheduled to caesarean section under general anaesthesia.
- Patients will be excluded in the event of transition to general anaesthesia or cancellation of the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta.
Read the detailed description
Preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta.
The aim of this study is to examine the efficacy of acupressure with co-stimulation of the "Yin-Tang" and "Shen-Men" points on the reduction in pre- and postoperative anxiety in elective caesarean section.
A single-blind, randomised, controlled, single-centre study will be conducted in ASA I or II patients undergoing elective caesarean section under perispinal anaesthesia. Patients will be randomised into two groups: the ACU+ group (co-stimulation of the "Yin-Tang" and "Shen-Men" points) and the ACU- group (stimulation of two sham points). Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) score and by measuring skin conductance (Electrodermal Activity [EDA]) during three periods: period 1 (at inclusion, in the patient's hospital room on the morning of the procedure), period 2 (before arrival in the operating theatre) and period 3 (in the postoperative recovery room). True or sham acupressure will be applied using adhesive beads positioned between periods 1 and 2 and left in place until the end of period 3.
- Conditions
- Cesarean Section, Pregnancy, Preoperative Anxiety
- Being tested
- ACUPRESSURE
- Keywords
- Acupressure, STAI (State Trait Anxiety Inventory), EDA (Electrodermal Activity)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUPRESSUREDevice
Acupressure using disposable devices consisting of a metal microbead and an adhesive material.
| Study group | Role | What they receive |
|---|---|---|
| ACUPLUS | Experimental | ACU+ : patients receives stimulation on the true experimental points (Yin-Tang + Shen-Men) Receives: Device: ACUPRESSURE |
| ACUMOINS | Placebo comparator | ACU- : patients receives stimulation on placebo points ("sham" point) Receives: Device: ACUPRESSURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Trait Anxiety Inventory (STAI) score
Difference between the two groups (ACU+ versus ACU-) in STAI score
Measured: At inclusion (the inclusion takes place on the morning of the surgery)
State Trait Anxiety Inventory (STAI) score
Difference between the two groups (ACU+ versus ACU-) in STAI score
Measured: At the entrance in the operative room (this event takes place from 20 minutes to 12 hours after the inclusion, depending on the availability of the surgeons to start the C-section)
State Trait Anxiety Inventory (STAI) score
Difference between the two groups (ACU+ versus ACU-) in STAI score
Measured: In the postoperative recovery room (this event takes place from 40 minutes to 16 hours after the inclusion, depending on the availability fo the surgeons to start the C-section and the duration of this one)
Secondary outcomes (3)
Electrodermal Activity (EDA)
Difference between the two groups (ACU+ versus ACU-) in EDA
Measured: At inclusion
Electrodermal Activity (EDA)
Difference between the two groups (ACU+ versus ACU-) in EDA
Measured: At the entrance in the operative room (this event takes place from 20 minutes to 12 hours after the inclusion, depending on the availability of the surgeons to start the C-section)
Electrodermal Activity (EDA)
Difference between the two groups (ACU+ versus ACU-) in EDA
Measured: In the postoperative recovery room (this event takes place from 40 minutes to 16 hours after the inclusion, depending on the availability fo the surgeons to start the C-section and the duration of this one)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start9 Jun 2022
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc LAFFON, MD,PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119971
- Sponsor's protocol ID
- ACUCESAR
- Acronym
- ACUCESAR
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure on the "Yin-Tang" and "Shen-Men" Points on Pre and Postoperative Anxiety in Elective Caesarean Section: a Prospective, Single-blind, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT06119971
- Acronym / sponsor ID
- ACUCESAR / ACUCESAR
- Conditions
- Cesarean Section, Pregnancy, Preoperative Anxiety
- Keywords
- Acupressure, STAI (State Trait Anxiety Inventory), EDA (Electrodermal Activity)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- 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 occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta.
Detailed description
Preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. Some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta.
The aim of this study is to examine the efficacy of acupressure with co-stimulation of the "Yin-Tang" and "Shen-Men" points on the reduction in pre- and postoperative anxiety in elective caesarean section.
A single-blind, randomised, controlled, single-centre study will be conducted in ASA I or II patients undergoing elective caesarean section under perispinal anaesthesia. Patients will be randomised into two groups: the ACU+ group (co-stimulation of the "Yin-Tang" and "Shen-Men" points) and the ACU- group (stimulation of two sham points). Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) score and by measuring skin conductance (Electrodermal Activity [EDA]) during three periods: period 1 (at inclusion, in the patient's hospital room on the morning of the procedure), period 2 (before arrival in the operating theatre) and period 3 (in the postoperative recovery room). True or sham acupressure will be applied using adhesive beads positioned between periods 1 and 2 and left in place until the end of period 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACUPLUS | Experimental | Device: ACUPRESSUREACU+ : patients receives stimulation on the true experimental points (Yin-Tang + Shen-Men) |
| ACUMOINS | Placebo comparator | Device: ACUPRESSUREACU- : patients receives stimulation on placebo points ("sham" point) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- informed consent obtained
- adult patients
- ASA class I or II
- scheduled caesarean section at CHRU Tours Maternity
- under perispinal anaesthesia (spinal anaesthesia or spinal and epidural anaesthesia combined)
Key exclusion criteria (8 listed)
- higher or equal to ASA class III
- heart rhythm disorder
- treated with a psychotropic drug (anxiolytic, sedative, antidepressant, antipsychotic, mood stabilizer)
- psychiatric history
- drug or alcohol abuse
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 |
|---|---|---|
| ACUPRESSUREAcupressure using disposable devices consisting of a metal microbead and an adhesive material. | Device | ACUMOINS, ACUPLUS |
Primary outcome
State Trait Anxiety Inventory (STAI) score
Time frame: At inclusion (the inclusion takes place on the morning of the surgery)
Difference between the two groups (ACU+ versus ACU-) in STAI score
State Trait Anxiety Inventory (STAI) score
Time frame: At the entrance in the operative room (this event takes place from 20 minutes to 12 hours after the inclusion, depending on the availability of the surgeons to start the C-section)
Difference between the two groups (ACU+ versus ACU-) in STAI score
State Trait Anxiety Inventory (STAI) score
Time frame: In the postoperative recovery room (this event takes place from 40 minutes to 16 hours after the inclusion, depending on the availability fo the surgeons to start the C-section and the duration of this one)
Difference between the two groups (ACU+ versus ACU-) in STAI score
3 secondary outcomes
Electrodermal Activity (EDA)
Time frame: At inclusion
Electrodermal Activity (EDA)
Time frame: At the entrance in the operative room (this event takes place from 20 minutes to 12 hours after the inclusion, depending on the availability of the surgeons to start the C-section)
Electrodermal Activity (EDA)
Time frame: In the postoperative recovery room (this event takes place from 40 minutes to 16 hours after the inclusion, depending on the availability fo the surgeons to start the C-section and the duration of this one)
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Marc LAFFON, MD,PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACUPRESSURE in people with Cesarean Section and Pregnancy, run by University Hospital, Tours 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 5 inclusion and 8 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 7 Nov 2023. 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?
State Trait Anxiety Inventory (STAI) score (time frame: At inclusion (the inclusion takes place on the morning of the surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.