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

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Completed

Conditions: Pain Postoperative; Caesarean Section; Pain

Treatments: Other: Auricular Acupressure; Other: Sham Auricular Acupressure Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07322601

3962/DHYD-HDDD

Details and patient eligibility

About

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.

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 Participants will be withdrawn from the study if they develop adverse reactions, including local allergic reactions at the patch site, persistent local pain, or severe dizziness.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Auricular Acupressure Group

Experimental group

Description:

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 \[Antihelix-6 (AH6)\].

Treatment:

Other: Auricular Acupressure

Sham Auricular Acupressure Group

Sham Comparator group

Description:

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

Treatment:

Other: Sham Auricular Acupressure Group