Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Houston Methodist Hospital
RECRUITING
Houston
Contact Information
Primary
Darrel Cleere, BSN RN CCRP
dwcleere@houstonmethodist.org
713-441-6232
Backup
Shondra Word
sword@houstonmethodist.org
713-441-5122
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 15
Treatments
Experimental: Patient participant
Two sessions per day of VoiceLove digital therapy will be administered with each session lasting 20-25 minutes. Sessions will occur during days 1-3 while the participant is in bed and in an alert and calm state.
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute

This content was sourced from clinicaltrials.gov