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

NCT06119971 | Completed

• 1 other identifier: ACUCESAR
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section; Pregnancy; Preoperative Anxiety

Keywords

Acupressure; STAI (State Trait Anxiety Inventory); EDA (Electrodermal Activity)

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• Electrodermal Activity (EDA)

  At inclusion

• Electrodermal Activity (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)

• Electrodermal Activity (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)

Study Arms (2)

ACUPLUS

EXPERIMENTAL

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

Device: ACUPRESSURE

ACUMOINS

PLACEBO COMPARATOR

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

Device: ACUPRESSURE

Interventions

ACUPRESSURE DEVICE

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

ACUMOINS; ACUPLUS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital Tours

Tours, 37044, France

Location

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Marc LAFFON, MD,PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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".
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: November 7, 2023
• Study Start: June 9, 2022
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)