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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2023-03-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Acupressure Applied Before Cesarean Delivery on Anxiety, Physiological Parameters and Fetal Heart Rate

NCT06953037

Caesarean Section Pregnant Women Anxiety Disorder

NOT_YET_RECRUITING NA

The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women

NCT05411289

Labor Pain

COMPLETED NA

The Effect of Massage and Acupressure on Labor Pain

NCT06057116

Labor Pain

COMPLETED NA

The Effects of Acupressure on Pain After Cesarean Section

NCT04337801

Postpartum Women

COMPLETED NA

Therapy on Perioperative Anxiety and Pain in Patients

NCT06970431

Music Therapy Anxiety Health Education

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section Pregnancy Preoperative Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

In this study, the acupuncturist is a registered anaesthetist doctor (=investigator) who also holds the Acupuncture Diploma of the Medicine Faculty of Paris. After opening an opaque and sealed envelope, this acupuncturist is in charge of stimulating the true or sham points for each patient, according to the allocated group. As an anaesthetist, he is also responsible of carrying out the anaesthesia. The other care providers (anaesthetic nurses and surgeons) and the patients are blinded. Notably, the primary outcome consists of a self-administered questionnaire. Moreover, to prevent any difference or modification in care according to the results of the questionnaire, the latter is only recovered when the patient leaves the postoperative recovery room. The randomisation list was created with EXCEL software. Finally, an independent person is in charge of the statistical analysis.

Considering the above, we describe the study as "single-blind".

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACUPLUS

ACU+ : patients receives stimulation on the true experimental points (Yin-Tang + Shen-Men)

Group Type EXPERIMENTAL

ACUPRESSURE

Intervention Type DEVICE

Acupressure using disposable devices consisting of a metal microbead and an adhesive material.

ACUMOINS

ACU- : patients receives stimulation on placebo points ("sham" point)

Group Type PLACEBO_COMPARATOR

ACUPRESSURE

Intervention Type DEVICE

Acupressure using disposable devices consisting of a metal microbead and an adhesive material.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ACUPRESSURE

Acupressure using disposable devices consisting of a metal microbead and an adhesive material.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No