Mobilisation in the EveNing to TreAt deLirium (MENTAL): protocol for a mixed-methods feasibility randomised controlled trial

David McWilliams, Elizabeth King, Peter Nydahl, Julie Lorraine Darbyshire, L Gallie, Dalia Barghouthy, C Bassford, Owen Gustafson

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INTRODUCTION: Delirium is common in critically ill patients and is associated with longer hospital stays, increased mortality and higher healthcare costs. A number of risk factors have been identified for the development of delirium in intensive care, two of which are sleep disturbance and immobilisation. Non-pharmacological interventions for the management of intensive care unit (ICU) delirium have been advocated, including sleep protocols and early mobilisation. However, there is a little published evidence evaluating the feasibility and acceptability of evening mobilisation.

METHODS AND ANALYSIS: Mobilisation in the EveNing to TreAt deLirium (MENTAL) is a two-centre, mixed-methods feasibility randomised controlled trial (RCT). Sixty patients will be recruited from ICUs at two acute NHS trusts and randomised on a 1:1 basis to receive additional evening mobilisation, delivered between 19:00 and 21:00, or standard care. The underpinning hypothesis is that the physical exertion associated with evening mobilisation will promote better sleep, subsequently having the potential to reduce delirium incidence. The primary objective is to assess the feasibility and acceptability of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semi-structured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.

ETHICS AND DISSEMINATION: Ethical approval has been obtained through the Wales Research and Ethics Committee 6 (22/WA/0106). Participants are required to provide written informed consent. We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.


Original languageEnglish
Article numbere066143
Number of pages7
JournalBMJ Open
Issue number2
Early online date3 Feb 2023
Publication statusPublished - Feb 2023

Bibliographical note

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:


This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. OG, Clinical Doctoral Research Fellow, NIHR301569, is funded by Health Education England (HEE)/National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NIHR, NHS or the UK Department of Health and Social Care.


  • Humans
  • Feasibility Studies
  • Delirium/therapy
  • Physical Therapy Modalities
  • Intensive Care Units
  • Critical Care/methods
  • Randomized Controlled s as Topic


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