Supportive Analgesic Effect of Auricular Acupressure (AA) After Cesarean Section (CS) (NCT07322601) | Clinical Trial Compass
CompletedNot Applicable
Supportive Analgesic Effect of Auricular Acupressure (AA) After Cesarean Section (CS)
Vietnam70 participantsStarted 2024-10-14
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: 12, 24, 48 hours postoperative
2
VAS scores for pain intensity at rest, pain intensity on movement, and uterine contraction pain
Timeframe: From enrollment to the end of treatment at 48 hours
Trial details
NCT IDNCT07322601
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City