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Completed

NCT Number: NCT04311437

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

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.

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Key information

Conditions

Hyperbaric Oxygen Therapy Middle Ear Barotrauma

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-acupressure therapy

Procedure

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.

Combined Valsalva and Toynbee maneuvers

Procedure

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.

Primary outcomes

  1. Modified Teed Classification

    Time frame: 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.

Secondary outcomes

  1. Symptoms of MEB

    Time frame: 1 month

    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).

  2. Overall ear discomfort levels

    Time frame: 1 month

    Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2020
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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