NCT03158909 2017.
Study name | Trial of a non‐pharmacological Intervention to prevent delirium among elderly in‐patients |
Methods | Randomised controlled study |
Participants | 284 patients (≥ 60 years) for inpatient stay at a Brazilian Hospital |
Interventions | Group 1: patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night Group 2: this group will receive orientations about space and time only, every night. |
Outcomes | Primary outcome: incidence cases of delirium up to 15 days from the inclusion in the study using the Confusion Assessment Method (Short‐CAM) Secondary outcome(s): sleep quality up to 15 days, safety of the intervention up to 15 days, acceptance, comfort and adherence to the intervention up to 15 days, use of psychotropic drugs up to 15 days, time of hospital stay up to 6 months, evaluation of the sleep‐wake cycle up to 15 days, urinary 6‐sulfatoxymelatonin levels 48 hours after admission |
Starting date | 15/01/2020 |
Contact information | Artur Schuh, schuh.afs@gmail.com Hospital de Clínicas de Porto Alegre |
Notes | ClinicalTrials.gov Identifier: NCT03158909 Status: recruiting (last update, 14/01/2020) |