Actively Recruiting
VoiceLove Digital Therapy for Delirium in the ICU
Led by The Methodist Hospital Research Institute · Updated on 2025-10-20
15
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a single-center, single-arm, prospective trial to evaluate the feasibility, safety, and acceptability of VoiceLOVE digital therapy for the management of delirium in surgical ICU patients. 15 participants will be enrolled. The study expects that 70% of participants will complete 20 -25 minutes of the VoiceLOVE digital therapy. Descriptive statistics will be used to summarize the findings. The intent is that this study will provide information for a larger, subsequent clinical trial of surgical ICU patients who are at risk for delirium.
CONDITIONS
Official Title
VoiceLove Digital Therapy for Delirium in the ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older admitted after major surgery
- Expected hospital stay of at least five days including at least three days in ICU
- At risk of delirium based on ICU delirium risk score or existing diagnosis
- Family members or caregivers involved in care are at least 18 years old
- Clinical team members caring for the patients
You will not qualify if you...
- History of severe mental illness
- Admission for drug overdose
- Severe vertigo
- History of severe postoperative nausea and vomiting
- Hearing or visual impairments
- Preexisting severe dementia (Montreal Cognitive Assessment Score less than 15)
- History of neurological surgeries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Darrel Cleere, BSN RN CCRP
CONTACT
S
Shondra Word
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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