Evaluation of the Supportive Analgesic Effect of Auricular Acupressure After Cesarean Section: A Randomized Clinical Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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 Participants will be withdrawn from the study if they develop adverse reactions, including local allergic reactions at the patch site, persistent local pain, or severe dizziness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Auricular Acupressure Group
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)].
干预措施: Auricular Acupressure (Other)
Sham Auricular Acupressure Group
Participants received identical adhesive patches without seeds applied to the same auricular points.
干预措施: Sham Auricular Acupressure Group (Other)
结局指标
主要结局
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.
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Lê Phương Linh
Medical Doctor
University of Medicine and Pharmacy at Ho Chi Minh City