VoiceLove recorded-family-voice therapy for ICU delirium

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

This study will try playing recorded messages from a loved one at the bedside to see if adults in the surgical ICU at risk for delirium can tolerate 20–25 minute sessions and find them acceptable.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Methodist Hospital Research Institute (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07218484 on ClinicalTrials.gov

What this trial studies

This is a single-center, single-arm, prospective feasibility trial enrolling 15 surgical ICU patients at risk for delirium. Recorded voice messages from a participant's loved one will be played at the bedside twice daily for 20–25 minutes each session. Participants have a preoperative visit, three consecutive intervention visits with vital sign checks, daily twice-daily CAM-ICU assessments for seven days, and daily RASS assessments for seven days, and will complete a system usability scale at study end. Descriptive statistics will summarize completion rates, safety, and acceptability to inform a larger subsequent trial.

Who should consider this trial

Good fit: Adults (≥18 years) admitted after major surgery who are expected to stay ≥5 days with at least a 3-day ICU stay and are at risk for delirium, with family or caregivers available to provide recordings, are ideal candidates.

Not a fit: Patients with severe dementia (MoCA <15), hearing or vision impairments, recent neurological surgery, severe mental illness, admission for drug overdose, severe vertigo, or severe postoperative nausea/vomiting are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could improve patient orientation and comfort and potentially shorten or reduce delirium symptoms in the ICU.

How similar studies have performed: Some prior work using familiar voices or music in hospital settings has shown promise for reducing delirium-related symptoms, but bedside recorded-loved-one interventions in the ICU remain preliminary.

Eligibility criteria

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.

Where this trial is running

Houston, Texas

• Houston Methodist Hospital — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Hina Faisal, MD — The Methodist Hospital Research Institute
• Study coordinator: Darrel Cleere, BSN RN CCRP

Conditions Delirium; delirium; intensive care unit; cognitive dysfunction; confusion