Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children Undergoing Adenoidectomy: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The incidence of emergence agitation
研究概览
简要总结
This study investigates whether auricular acupressure can reduce postoperative emergence agitation among preschool children following adenoidectomy.
详细描述
Emergence agitation is a frequent complication after pediatric head and neck surgery. Despite this, evidence for non-pharmacological preventive strategies is limited. This study explores the efficacy of auricular acupressure, a non-invasive Traditional Chinese Medicine technique, in preventing postoperative agitation among these children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) American Society of Anesthesiologists (ASA) physical status classification of I to III; (2) Children aged 3 to 6 years scheduled for elective adenoidectomy; (3) No damage to the epidermis of the external ear.
排除标准
- •(1) Children taking anti-anxiety or antidepressant medications; (2) Children with a history of psychiatric disorders or current psychiatric abnormalities; (3) Children with cognitive deficits or cognitive and intellectual developmental disorders; (4) Children with allergies to auricular acupressure beads; (5) Participation in other clinical trials within the past three months.
研究组 & 干预措施
Auricular acupressure
Auricular acupressure is a non-invasive technique derived from traditional Chinese medicine (TCM), where small seeds (typically from Vaccaria segetalis plants) or magnetic beads are attached to specific points on the outer ear using adhesive tape.Patients in the experimental group received auricular acupressure at the following points: Main points: Shenmen (TF4), Endocrine (CO18), Sympathetic (AH6a), Subcortex (AT4); Auxiliary points: Heart (CO15), Liver (CO12), Anterior Lobe (AT3). The location of acupoints was determined in accordance with the World Health Organization (WHO) International Standard Terminologies for Auricular Acupuncture, as specified in WHO Standard Acupuncture Point Locations in the Western Pacific Region (ISBN 978-92-9061-248-7).Acupressure details are as followings: (1) Bilateral ear acupoints. (2) Each point was compressed until deqi was achieved. (3) Deqi manifested as soreness, numbness, distension, or warmth.
干预措施: Auricular acupressure (Device)
Sham Auricular acupressure
For children in the sham stimulation group, we followed the same consultation and auricular point localization procedures, but no Vaccaria seed pressure stimulation was applied. Instead, only an adhesive patch of identical appearance was affixed to the skin.
干预措施: sham auricular acupressure (Device)
结局指标
主要结局
The incidence of emergence agitation
时间窗: The period from the patient's entry into the Post-Anesthesia Care Unit (PACU) until their discharge from the PACU.
During the anesthesia emergence period assessments were conducted at 5-minute intervals for 15 minutes, recording the Pediatric Anesthesia Emergence Delirium (PAED) scale.The highest recorded score was used, with a PAED score≥10 defined as the occurrence of emergence delirium.The incidence of emergence agitation was calculated according to the scale scores.
次要结局
- the score of FLACC (Face, Legs, Activity, Cry, Consolability)(During the patient's entire PACU stay.)
- Preoperative anxiety score of mYPAS （modified Yale Preoperative Anxiety Scale)(At the moment before entering the operating room.)
- the score of Induction Compliance Checklist during anesthetic induction(during anesthetic induction)
- The incidence of postoperative complications(PACU stay duration)
- the score of Post-Hospitalization Behavior Questionnaire (PHBQ)(At 1 month and 3 months postoperatively)