Recruiting

VoiceLOVE

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT07218484

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VoiceLove therapy

Study Details

Brief 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.

Conditions

Delirium

Study ID

NCT07218484

Start date

Aug 21, 2025

Status verified date

Oct, 2025

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jan 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

VoiceLove therapy

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.

Primary outcome measure

  • Feasibility of VoiceLove digital therapy use by participants in the ICU [ Time Frame: Baseline to day 3 ]

Central Contacts and Locations

Central contacts

Darrel Cleere, BSN RN CCRP

713-441-6232dwcleere@houstonmethodist.org

Shondra Word

713-441-5122sword@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Darrel Cleere, BSN RN CCRP

713-441-6232dwcleere@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • delirium
  • intensive care unit
  • cognitive dysfunction
  • confusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2025-10-20.