Dataset Information

Effect of self-acupressure on middle ear barotrauma associated with hyperbaric oxygen therapy: A nonrandomized clinical trial.

ABSTRACT:

Background

In hyperbaric oxygen therapy (HBOT), a patient is exposed to pure oxygen in a chamber. While HBOT is a long-standing and well-established treatment for a wide variety of medical conditions, one of the main complications is middle ear barotrauma (MEB), which can lead to complaints of ear discomfort, stuffiness or fullness in the ear, and difficulties in equalizing ear pressure. The aim of this study is to evaluate the efficacy of self-acupressure in preventing and reducing the degree of MEB associated with HBOT.

Methods

This is a prospective nonrandomized controlled study. A sample of 152 participants will be assigned to 2 groups in a 1:1 ratio. The participants in the control group will receive conventional Valsalva and Toynbee maneuvers, while those in the experimental group will be given additional self-acupressure therapy. The acupoints used will be TE17 (Yifeng), TE21 (Ermen), SI19 (Tinggong), and GB2 (Tinghui). The Modified Teed Classification, symptoms of MEB, and overall ear discomfort levels will be assessed. Data will be analyzed using the Chi-Squared test or t test.

Objectives

This study aims to evaluate the efficacy of self-acupressure for preventing and reducing the degree of MEB associated with HBOT.

Trial registration

ClinicalTrials.gov Identifier: NCT04311437. Registered on 17 March, 2020.

SUBMITTER: Chen JM

PROVIDER: S-EPMC8084020 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Publications

Effect of self-acupressure on middle ear barotrauma associated with hyperbaric oxygen therapy: A nonrandomized clinical trial.

Chen Jen-Ming JM Lu Zheng-Nan ZN Wu Re-Wen RW Bi Kuo-Wei KW Liu Chun-Ting CT

Medicine 20210401 17

<h4>Background</h4>In hyperbaric oxygen therapy (HBOT), a patient is exposed to pure oxygen in a chamber. While HBOT is a long-standing and well-established treatment for a wide variety of medical conditions, one of the main complications is middle ear barotrauma (MEB), which can lead to complaints of ear discomfort, stuffiness or fullness in the ear, and difficulties in equalizing ear pressure. The aim of this study is to evaluate the efficacy of self-acupressure in preventing and reducing the ...[more]

PMID: 33907136

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Project description:BackgroundChronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing.ObjectivesTo assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb.Search methodsFor this second update we searched the Cochrane Wounds Group Specialised Register (searched 18 February 2015); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 1); Ovid MEDLINE (1946 to 17 February 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 17 February 2015); Ovid EMBASE (1974 to 17 February 2015); and EBSCO CINAHL (1982 to 17 February 2015).Selection criteriaRandomised controlled trials (RCTs) comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).Data collection and analysisThree review authors independently evaluated the risk of bias of the relevant trials using the Cochrane methodology and extracted the data from the included trials. We resolved any disagreement by discussion.Main resultsWe included twelve trials (577 participants). Ten trials (531 participants) enrolled people with a diabetic foot ulcer: pooled data of five trials with 205 participants showed an increase in the rate of ulcer healing (risk ratio (RR) 2.35, 95% confidence interval (CI) 1.19 to 4.62; P = 0.01) with HBOT at six weeks but this benefit was not evident at longer-term follow-up at one year. There was no statistically significant difference in major amputation rate (pooled data of five trials with 312 participants, RR 0.36, 95% CI 0.11 to 1.18). One trial (16 participants) considered venous ulcers and reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and number of ulcers healed) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at six weeks (mean difference (MD) 33.00%, 95% CI 18.97 to 47.03, P < 0.00001). We identified one trial (30 participants) which enrolled patients with non-healing diabetic ulcers as well as venous ulcers ("mixed ulcers types") and patients were treated for 30 days. For this "mixed ulcers" there was a significant benefit of HBOT in terms of reduction in ulcer area at the end of treatment (30 days) (MD 61.88%, 95% CI 41.91 to 81.85, P < 0.00001). We did not identify any trials that considered arterial and pressure ulcers.Authors' conclusionsIn people with foot ulcers due to diabetes, HBOT significantly improved the ulcers healed in the short term but not the long term and the trials had various flaws in design and/or reporting that means we are not confident in the results. More trials are needed to properly evaluate HBOT in people with chronic wounds; these trials must be adequately powered and designed to minimise all kinds of bias.

Dataset Information

Effect of self-acupressure on middle ear barotrauma associated with hyperbaric oxygen therapy: A nonrandomized clinical trial.

Background

Methods

Objectives

Trial registration

Publications

Effect of self-acupressure on middle ear barotrauma associated with hyperbaric oxygen therapy: A nonrandomized clinical trial.

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