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NCT Number: NCT06119971

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

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.

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Key information

Conditions

Cesarean Section Pregnancy Preoperative Anxiety

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tours

Tours, 37044, France

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACUPRESSURE

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Electrodermal Activity (EDA)

    Time frame: At inclusion

    Difference between the two groups (ACU+ versus ACU-) in EDA

  2. 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)

    Difference between the two groups (ACU+ versus ACU-) in EDA

  3. 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)

    Difference between the two groups (ACU+ versus ACU-) in EDA

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: ACUCESAR

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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