Pregnancy Clinical Trial
— ACUCESAROfficial 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
NCT number | NCT06119971 |
Other study ID # | ACUCESAR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 9, 2022 |
Est. completion date | March 8, 2023 |
Verified date | October 2023 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 8, 2023 |
Est. primary completion date | March 8, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | State Trait Anxiety Inventory (STAI) score | Difference between the two groups (ACU+ versus ACU-) in STAI score | At inclusion (the inclusion takes place on the morning of the surgery) | |
Primary | State Trait Anxiety Inventory (STAI) score | Difference between the two groups (ACU+ versus ACU-) in STAI score | 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) | |
Primary | State Trait Anxiety Inventory (STAI) score | Difference between the two groups (ACU+ versus ACU-) in STAI score | 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 | Electrodermal Activity (EDA) | Difference between the two groups (ACU+ versus ACU-) in EDA | At inclusion | |
Secondary | Electrodermal Activity (EDA) | Difference between the two groups (ACU+ versus ACU-) in EDA | 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) | |
Secondary | Electrodermal Activity (EDA) | Difference between the two groups (ACU+ versus ACU-) in EDA | 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) |
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