Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-08-21
2026-01-31
Brief Summary
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Detailed Description
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Participants will have a pre-operative visit, 3 consecutive intervention visits with vital signs assessment, 7 days of assessments of Confusion Assessment Methods (CAM)-ICU (morning and evening), and 7 days of a Richmond Agitation-Sedation Scale assessment. The participant will provide an assessment of the acceptability of the VoiceLove digital therapy using a system usability scale score at the end of their participation in the study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Hina Faisal, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Houston Methodist Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Darrel Cleere, BSN RN CCRP
Role: primary
Other Identifiers
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PRO00041572
Identifier Type: -
Identifier Source: org_study_id