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VoiceLove Digital Therapy for Delirium in the ICU

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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1. 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
2. At risk of delirium, as per ICU delirium risk score or existing diagnosis
3. Family members or caregivers involved in patient care at least 18 years of age.
4. Clinical team members caring for the patients

Exclusion Criteria:

* Patients in the ICU who have

  1. a history of severe mental illness,
  2. admission for a drug overdose,
  3. severe vertigo,
  4. a history of severe postoperative nausea and vomiting,
  5. hearing or visual impairments,
  6. preexisting severe dementia (Montreal Cognitive Assessment Score \<15),
  7. neurological surgeries.

About the study

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.

What is being tested

• VoiceLove therapy (behavioral)

Sponsor: The Methodist Hospital Research Institute · Participants: 15 · Started: Aug 21, 2025

Contact the study team

• Darrel Cleere, BSN RN CCRP · Phone: 713-441-6232
• Shondra Word · Phone: 713-441-5122

Official record on ClinicalTrials.gov — NCT07218484

Locations in the U.S.

Conditions

• Delirium
• Mild Cognitive Impairment
• Confusion

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.