Phase II trial to evaluate the safety, feasibility and efficacy of using therapeutic weighted blankets for agitation in patients with dementia in acute care settings.

Use of a therapeutic weighted blanket for patients with a diagnosis of dementia, who have experienced agitation in acute care. Upon settling acute care patients who have dementia and have experienced agitation during their hospitalisation for the evening (and in conjunction with the nurse caring for the patient), the research assistant will apply an appropriately weighted blanket based on the patient’s weight (less than 10% of the patient’s body weight) on patients randomised to the intervention arm. Each participant will only receive the intervention once and the research assistant will supervise the participant for the duration of blanket use. The blankets to be used in the trial will weigh 5.5kg, 6.6kg or 7.7kgs. Where a blanket is greater than 10% of a patient’s body weight the patient shall be deemed ineligible for the intervention group. Weighted blankets will be able to be removed by individuals should they wish, this will be documented as the study endpoint, and the time applied/ tolerated will be recorded. There are no standardised guidelines for the safe use of weighted blankets by people in hospital settings. Parameters have been adapted from Harris and Titler (2022) whose study tested safety and effectiveness in people with dementia in the home environment and they did not report any adverse events. The blanket will be placed no higher than the patient’s shoulder tip and not below the ankles. Blankets will be placed for a period of no longer than 60 minutes, or until such time as the patient removes the blanket themselves.