VoiceLove Digital Therapy for Delirium in the ICU
Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study
The Methodist Hospital Research Institute
15 participants
Aug 21, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Men and women aged ≥18 years admitted to the hospital after major surgery (elective or non-elective) require a hospital stay of at least five days following surgery, including an ICU stay for at least three days after the surgical procedure
- At risk of delirium, as per ICU delirium risk score or existing diagnosis
- Family members or caregivers involved in patient care at least 18 years of age.
- Clinical team members caring for the patients
Exclusion Criteria8
- Patients in the ICU who have
- a history of severe mental illness,
- admission for a drug overdose,
- severe vertigo,
- a history of severe postoperative nausea and vomiting,
- hearing or visual impairments,
- preexisting severe dementia (Montreal Cognitive Assessment Score <15),
- neurological surgeries.
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Interventions
VoiceLove digital interventions represent voice recordings, specifically, (i) Reorientation messages, and (ii) general communication domain calming and encouraging voice messages recorded in familiar voices from family and friends. Families will be guided to record and deliver Reorientation messages, that can be played to the patient.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07218484