Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy: a Nonrandomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Modified Teed Classification
研究概览
简要总结
Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy (HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic membrane associated with HBOT. Currently, there is no optimal prophylactic management for MEB associated with HBOT. The aim of this protocol is to investigate the efficacy of self-acupressure therapy on MEB associated with HBOT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 years or order receiving the first HBOT
- •Alert consciousness
排除标准
- •Pregnancy
- •Having any acute disorder of the ears or upper respiratory tract
- •Having evidence of neurologic dysfunction precluding them from making an informed decision
- •Having a tracheostomy or endotracheal intubation
- •Having received a myringotomy, tympanoplasty, mastoidectomy or tympanostomy tube placement.
研究组 & 干预措施
Self-acupressure group
The subjects in experimental group will undergo additional self-acupressure therapy in addition to Valsalva and Toynbee maneuvers before the first HBOT. The acupoints used are TE17 (Yifeng, 翳風), TE21 (Ermen, 耳門), SI19 (Tinggong, 聽宮), GB2 (Tinghui, 聽會).
干预措施: Self-acupressure therapy (Procedure)
Self-acupressure group
The subjects in experimental group will undergo additional self-acupressure therapy in addition to Valsalva and Toynbee maneuvers before the first HBOT. The acupoints used are TE17 (Yifeng, 翳風), TE21 (Ermen, 耳門), SI19 (Tinggong, 聽宮), GB2 (Tinghui, 聽會).
干预措施: Combined Valsalva and Toynbee maneuvers (Procedure)
Control group
The subjects in control group will receive Valsalva and Toynbee maneuvers alone.
干预措施: Combined Valsalva and Toynbee maneuvers (Procedure)
结局指标
主要结局
Modified Teed Classification
时间窗: 1 month
The Modified Teed Classification, with grades from 0 to 5: Grade 0 indicates symptoms with no ontological signs of trauma; Grade 1 indicates injection of the tympanic membrane; Grade 2 indicates Grade 1 plus injection plus mild hemorrhage within the tympanic membrane; Grade 3 indicates gross hemorrhage within the tympanic membrane; Grade 4 indicates free blood in the middle ear as evidenced by blueness and bulging; and Grade 5 indicates perforation of the tympanic membrane.
次要结局
- Symptoms of MEB(1 month)
- Overall ear discomfort levels(1 month)