Caesarean Section; Pain, Pain Postoperative
Conditions
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.
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 Participants will be withdrawn from the study if they develop adverse reactions, including local allergic reactions at the patch site, persistent local pain, or severe dizziness.
Interventions
OTHERAuricular 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.
OTHERSham 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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Participants were randomly assigned to the auricular acupressure group or sham auricular acupressure group in a 1:1 ratio.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| VAS scores for pain intensity at rest, pain intensity on movement, and uterine contraction pain | 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. |
Countries
Vietnam
Outcome results
None listed