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Trials / Completed

CompletedNCT07322601

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

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.

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 Participants will be withdrawn from the study if they develop adverse reactions, including local allergic reactions at the patch site, persistent local pain, or severe dizziness.

Conditions

Interventions

TypeNameDescription
OTHERAuricular AcupressureIn 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.
OTHERSham Auricular Acupressure GroupIn 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.

Timeline

Start date
2024-10-14
Primary completion
2025-06-30
Completion
2025-06-30
First posted
2026-01-07
Last updated
2026-01-07

Locations

1 site across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT07322601. Inclusion in this directory is not an endorsement.

Supportive Analgesic Effect of Auricular Acupressure (AA) After Cesarean Section (CS) (NCT07322601) · Clinical Trials Directory