Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy: a Nonrandomized Clinical Trial

Conditions
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Hyperbaric Oxygen Therapy, Middle Ear Barotrauma

Intervention / Treatment
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* Procedure: Self-acupressure therapy
* Procedure: Combined Valsalva and Toynbee maneuvers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 20 years or order receiving the first HBOT Alert consciousness Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-acupressure group<br>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). | Procedure: Self-acupressure therapy<br>* The self-acupressure therapy is as follows: Patients are in sitting position, applied firm pressure (3-5 kg of pressure) with the fingertips in a circular motion at a speed of two circles per second for a duration of one min per acupoint. A 1-2-s rest is applied after each ten circles. The complete process lasts for about 5 min.<br>Procedure: Combined Valsalva and Toynbee maneuvers<br>* Valsalva maneuver: blowing against a closed mouth and nostrils, increasing the middle ear pressure. Toynbee maneuver: swallowing while the mouth and nostrils are closed, decreasing the middle ear pressure.<br>|
| Placebo Comparator: Control group<br>The subjects in control group will receive Valsalva and Toynbee maneuvers alone. | Procedure: Combined Valsalva and Toynbee maneuvers<br>* Valsalva maneuver: blowing against a closed mouth and nostrils, increasing the middle ear pressure. Toynbee maneuver: swallowing while the mouth and nostrils are closed, decreasing the middle ear pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Teed Classification | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of MEB | Record the symptoms of MEB including feeling pressure in the ears, ear pain, headache, dizziness, vertigo, tinnitus and hearing loss. Each symptom is estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort). | 1 month | 
| Overall ear discomfort levels | Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort). | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperbaric oxygen therapy, Middle ear barotrauma, Acupressure