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Family-simulated Delirium Reduction Empowered by Audio-guided Multisensory Stimulation (F-DREAMS) in Critically Ill Patients: A Randomized Controlled Trial

Family-simulated Delirium Reduction Empowered by Audio-guided Multisensory Stimulation (F-DREAMS) in Critically Ill Patients: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118789
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-02-15
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Interventions

A Group (F-DREAMS Intervention Group):F-DREAMS intervention on top of standard care
B Group (Control Group):Standard care only

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged >=18 years admitted to the ICU; 2. Anticipated length of ICU stay to be at least 48 hours; 3. A delirium risk score of >=20% as assessed by the PRE-DELIRIC prediction model; 4. Informed consent provided and signed by the patient or their legally authorized representative; 5. Availability of a close relative or familiar family member willing to provide audio recordings and sensory stimulation materials as per the researcher's instructions.

Exclusion criteria

Exclusion criteria: 1. Patients with severe impairments in vision, hearing, smell, or touch, rendering them unable to effectively receive gentle multisensory stimulation (including but not limited to bilateral deafness, bilateral blindness, bilateral upper limb amputation); or 2. Patients in a terminal or emergent resuscitation state; or 3. Patients with increased intracranial pressure or any neurological condition contraindicated for sensory stimulation; or 4. Patients with a history of neurological disorders or any other condition causing severe cognitive impairment or communication difficulties; or 5. Patients whose family members providing recordings have had minimal or no contact in recent years, or where significant language/cultural differences exist, or who may introduce negative or distressing emotional content; or 6. Patients diagnosed with delirium prior to ICU admission; or 7. Patients with a Richmond Agitation-Sedation Scale (RASS) score < -3 and/or Glasgow Coma Scale (GCS) score < 8; or 8. Patients currently enrolled in other clinical trials; or 9. Patients (and their families) deemed unsuitable for the study by the researchers for any other reason.

Design outcomes

Primary

MeasureTime frame
Delirium Incidence Rate;

Secondary

MeasureTime frame
Delirium Severity;Delirium Frequency;Delirium Duration;Duration of Mechanical Ventilation;ICU Length of Stay;Hospital Length of Stay;Long-term Clinical Outcomes Follow-up;

Countries

China

Contacts

Public ContactYao Zhuangyan

Affiliated Hospital of Guangdong Medical University

Iris524001@163.com+86 759 2387414

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026