Tokyo, Oct. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063095) titled 'Intervention Study on Non-Pharmacological Delirium Prevention for Patients in High Care Units' on Oct. 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - National Hospital Organization Kanmon Medical Center
Condition:
Condition - delirium
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will implement non-pharmacological interventions aimed at preventing delirium for patients in our hospital's High Care Unit (HCU). Specifically, the intervention involves engaging patients in conversation during the day and having them watch videos of their choice to promote wakefulness; this aims to maintain the daytime circadian rhythm and ensure nighttime sleep, thereby preventing delirium. We will evaluate the efficacy of this intervention.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Using a DVD player, the patient watches a video selected from a list of video titles for 30 minutes each at 10:00 a.m. and 2:00 p.m.
Interventions/Control_2 - don't intervene
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients meeting all of the following criteria are eligible:
1) Patients expected to be admitted to the hospital's HCU for 7 days or longer
2) Patients aged 20 years or older at the time of obtaining consent
3) Gender: No restriction
4) Patients who have provided written consent of their own free will, based on a full understanding after receiving a thorough explanation regarding participation in this study
Key exclusion criteria - Patients meeting any of the following criteria shall be excluded from this study:
1) Patients with a history of dementia
2) Patients with a history of severe mental illness
3) Patients already in a state of delirium upon admission to the HCU
4) Patients with organic central nervous system disorders
5) Patients expected to remain in a prolonged coma
6) Patients with severe difficulty in language comprehension
7) Patients receiving end-of-life or palliative care
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 18 Day
Anticipated trial start date - 2026 Year 10 Month 05 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072227
Disclaimer: Curated by HT Syndication.