Supportive Analgesic Effect of Auricular Acupressure (AA) After Cesarean Section (CS) (AA-CS)

Evaluation of the Supportive Analgesic Effect of Auricular Acupressure After Cesarean Section: A Randomized Clinical Controlled Trial

Introduction:

Severe acute pain after cesarean section is an independent risk factor for the development of chronic pain and increases the risk of postpartum depression threefold. Pain also reduces the mother's ability to breastfeed and care for her child. This study aimed to evaluate the supportive effectiveness of auricular acupressure in reducing incision pain and uterine contraction pain in women undergoing cesarean section, compared with sham auricular acupressure.

Methods:

A randomized, controlled, single-blind clinical trial was conducted in seventy women undergoing cesarean section, randomly allocated (1:1) to an auricular acupressure or sham group. The study group received vaccaria seeds, and the sham group received non-vaccaria patches on both ears. Both groups were treated at the Shenmen, Lung, Internal Genitalia, Pelvis, Subcortex, and Sympathetic points. Pain was assessed using the Visual Analog Scale (VAS), and diclofenac consumption was recorded over the first 48 hours postpartum.

Study Overview

• Status: Completed
• Conditions: Caesarean Section; Pain; Pain Postoperative
• Intervention / Treatment: Other: Auricular Acupressure; Other: Sham Auricular Acupressure Group

Detailed Description

Participants are instructed to apply pressure to the patches three times daily (morning, noon, and evening). Supplemental acupressure is also performed whenever the participant feels pain, with the goal of achieving the 'De-qi' sensation (a feeling of soreness or tingling). All patches are maintained for 48 hours. Postoperative analgesia follows a standardized hospital protocol, with diclofenac administered as rescue medication.

Safety monitoring is strictly implemented throughout the study. If participants experience symptoms such as headache, dizziness, or syncope following the application of auricular patches, they will be managed according to standardized acupuncture safety protocols. Participants will be withdrawn from the study if they develop adverse reactions, including local allergic reactions at the patch site, persistent local pain, or severe dizziness.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Binh Trung Ward
    • Ho Chi Minh City, Binh Trung Ward, Vietnam
      • Le Van Thinh Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-40 years of age
• Gestational age ≥ 37 weeks
• Alert and cooperative with the treating physicians
• Able to understand and use the Visual Analog Scale (VAS)
• Preoperative American Society of Anesthesiologists (ASA) Physical Status Classification System I-II
• Anesthesia: spinal anesthesia;
• Pfannenstiel suprapubic transverse incision
• Infant 5-minute Appearance, Pulse, Grimace, Activity, Respiration score (Apgar score) > 7
• Cesarean operative time ≤ 60 minutes
• Singleton pregnancy
• Voluntary agreement to participate.

Exclusion Criteria:

• Contraindication to diclofenac
• Surgical complications, including hysterectomy and postpartum hemorrhage (> 1000 ml)
• History of acupuncture syncope
• Preoperative chronic pain and/or regular preoperative use of analgesics
• Addiction to or dependence on opioids or alcohol
• Diabetes mellitus or HIV infection
• Prior Auricular acupressure
• Skin lesions of the auricle
• Surgical wound infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular Acupressure Group; Participants received auricular acupressure using Vaccaria seeds applied to Shenmen [Antitragus-4 (TF4)], Lung [Concha-14 (CO14)], Internal Genitalia [Triangular fossa-2 (TF2)], Pelvis [Triangular fossa-5 (TF5)], Subcortex [Antitragus-4 (AT4)], and Sympathetic [Antihelix-6 (AH6)].	Other: Auricular Acupressure; In the Auricular Acupressure group, participants received auricular acupressure using vaccaria seeds applied to the following points on both ears: Ear Shenmen (TF4), Lung (CO14), Internal Genitalia (TF2), Pelvis (TF5), Subcortex (AT4), and Sympathetic (AH6), in addition to standard postoperative care. Each participant received a single treatment session within 5 hours after cesarean section, once transferred to the Obstetrics Department. Seeds were retained for 2 days. All acupuncture procedures were performed by licensed traditional medicine physicians who had been trained and standardized before the study.; Other Names: Acupuncture; Auricular Acupuncture
Sham Comparator: Sham Auricular Acupressure Group; Participants received identical adhesive patches without seeds applied to the same auricular points.	Other: Sham Auricular Acupressure Group; In the Sham Auricular Acupressure Group, participants received adhesive patches without seeds, identical in size and appearance to the Auricular Acupressure Group patches, applied to the same auricular points. Both groups received standard postoperative care.; Other Names: Sham Acupuncture; Sham Auricular Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section.	Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section. The Visual Analog Scale (VAS) consists of a line where respondents are asked to mark their level of pain. The left-most point (zero) represents no pain and the right-most point (10) represents extreme pain. The higher the score, the more severe the pain.	12, 24, 48 hours postoperative
VAS scores for pain intensity at rest, pain intensity on movement, and uterine contraction pain	Pain relief effectiveness was assessed using the Visual Analog Scale (VAS) for pain intensity at rest, during movement and for uterine contractions at 12, 24, and 48 hours after cesarean section. The Visual Analog Scale (VAS) consists of a line where respondents are asked to mark their level of pain. The left-most point (0) represents 'no pain,' while the right-most point (10) represents 'extreme pain.' The higher the score, the more severe the pain.	From enrollment to the end of treatment at 48 hours

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Investigators: Study Chair: Ly, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative; Therapeutics; Complementary Therapies; Auriculotherapy; Acupuncture Therapy; Acupuncture, Ear
• Other Study ID Numbers: 3962/DHYD-HDDD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The type of data set or supporting information being shared. Options include: study protocol, statistical analysis plan, informed consent form, clinical study report, analytic code.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results
• IPD Sharing Access Criteria: Data will be made available to qualified researchers for the purpose of valid scientific research. To gain access, investigators must submit a formal research proposal and a statistically sound analysis plan to the Principal Investigator. All requests will be reviewed by the study's investigators and the Institutional Ethics Committee. Upon approval, requestors will be required to sign a Data Use Agreement (DUA) to ensure participant confidentiality. The shared data will be de-identified and may include the study protocol and statistical analysis plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No