ACUCESAR: 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

• Sponsor: University Hospital, Tours (Other)
• Overall Status: Completed
• CT.gov ID: NCT06119971
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section; Pregnancy; Preoperative Anxiety	Device: ACUPRESSURE	N/A

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

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: 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".
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 9, 2022
• Actual Primary Completion Date: Mar 8, 2023
• Actual Study Completion Date: Mar 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACUPLUS ACU+ : patients receives stimulation on the true experimental points (Yin-Tang + Shen-Men)	Device: ACUPRESSURE; Acupressure using disposable devices consisting of a metal microbead and an adhesive material.
Placebo Comparator: ACUMOINS ACU- : patients receives stimulation on placebo points ("sham" point)	Device: ACUPRESSURE; Acupressure using disposable devices consisting of a metal microbead and an adhesive material.

Outcome Measures

Primary Outcome Measures

1. State Trait Anxiety Inventory (STAI) score [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 [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 [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 Outcome Measures

1. Electrodermal Activity (EDA) [At inclusion]

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

2. 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)]

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

3. 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)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Tours	Tours		France	37044

Sponsors and Collaborators

• University Hospital, Tours

Investigators

• Principal Investigator: Marc LAFFON, MD,PhD, University Hospital, Tours

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Tours
• ClinicalTrials.gov Identifier: NCT06119971
• Other Study ID Numbers: ACUCESAR
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Tours: Acupressure; STAI (State Trait Anxiety Inventory); EDA (Electrodermal Activity)
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Nov 7, 2023