Validation of sham treatment in hyperbaric medicine: a randomised trial.

ABSTRACT:

Introduction

This study aimed to determine the lowest possible atmospheric pressure in the 111-152 kPa (1.1-1.5 atmospheres absolute [atm abs]) range that would require the patients to equalise their ears, allowing an effective sham for a 203 kPa (2.0 atm abs) hyperbaric exposure.

Methods

We performed a randomised controlled study on 60 volunteers divided into 3 groups (compression to 111, 132 and 152 kPa (1.1, 1.3, 1.5 atm abs) to determine the minimum pressure to obtain blinding. Secondly, we applied additional blinding strategies (faster compression with ventilation during the fictitious compression time, heating at compression, cooling at decompression) on 25 new volunteers in order to enhance blinding.

Results

The number of participants who did not believe they h

SUBMITTER: Louge P 

PROVIDER: S-EPMC10318180 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature