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

NCT07322601 | Completed

• 1 other identifier: 3962/DHYD-HDDD
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Postoperative; Caesarean Section; Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Auricular Acupressure Group

EXPERIMENTAL

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

Sham Auricular Acupressure Group

SHAM COMPARATOR

Participants received identical adhesive patches without seeds applied to the same auricular points.

Other: Sham Auricular Acupressure Group

Interventions

Auricular Acupressure OTHER

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.

Also known as: Auricular Acupuncture, Acupuncture

Auricular Acupressure Group

Sham Auricular Acupressure Group OTHER

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.

Also known as: Sham Acupuncture, Sham Auricular Acupuncture

Sham Auricular Acupressure Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Le Van Thinh Hospital

Ho Chi Minh City, Binh Trung Ward, Vietnam

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Acupuncture, Ear; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Ly, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Participants were randomly assigned to the auricular acupressure group or sham auricular acupressure group in a 1:1 ratio.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 7, 2026
• Study Start: October 14, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• 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.

Locations

VN (1)