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NCT Number: NCT07322601

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

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Le Van Thinh Hospital

Ho Chi Minh City, Binh Trung Ward, Vietnam

About this study

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 Participants will be withdrawn from the study if they develop adverse reactions, including local allergic reactions at the patch site, persistent local pain, or severe dizziness.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Other names: Auricular Acupuncture, Acupuncture

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.

Other names: Sham Acupuncture, Sham Auricular Acupuncture

Primary outcomes

  1. 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.

    Time frame: 12, 24, 48 hours postoperative

    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.

  2. VAS scores for pain intensity at rest, pain intensity on movement, and uterine contraction pain

    Time frame: From enrollment to the end of treatment at 48 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

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

Acronym: AA-CS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

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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