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Itinai.com a close up shot of a scientist wearing a pristine db6a7c73 f520 44e3 bb74 10eabe38d600 3

Effect of melatonin versus placebo for prevention of delirium among medically hospitalised patients: study protocol for a single-centre, double-blinded, randomised controlled trial (project RESTORE)

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Introduction

Delirium is a common and serious condition in older patients in hospitals. It can lead to higher death rates, longer stays in the hospital, and problems with thinking. Researchers are looking into whether melatonin can help prevent delirium by improving sleep and regulating body rhythms. This study will see how well melatonin works for patients aged 65 and older in the hospital.

Study Overview

This study, called project RESTORE, is a randomised, double-blind trial that will include 240 older patients at Sultan Qaboos University Hospital starting in September 2024. Participants will receive either 5 mg or 8 mg of melatonin or a placebo each night for up to 5 days.

Goals of the Study

The main goal is to measure how many patients develop delirium during the first 5 days. Other goals include:

  • The length of any delirium episodes
  • How well patients sleep
  • The length of time they stay in the hospital
  • The rate of readmission within 28 days

Ethics and Data Sharing

The study has ethical approval and informed consent will be obtained from all participants or their representatives. Results will be shared through medical journals and conferences to enhance knowledge about preventing delirium in older hospital patients.

Next Steps

After analyzing the trial data, healthcare providers can:

  • Define clear and measurable outcomes for their practice.
  • Choose AI tools that meet specific clinical needs.
  • Implement a pilot project and track results using AI, comparing them to the study findings.

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