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The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Delirium, Intensive Care Unit, Randomised Controlled Trial

Treatments

Other: Sensory stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04306016
2019.521

Details and patient eligibility

About

Delirium is highly associated with adverse clinical outcomes of intensive care unit (ICU) patients, including increased cognitive impairment, duration of intubation, ICU length of stay, mortality, physical dependence, and health care costs. This randomised controlled study will firstly develop a family-supported sensory stimulation package based on the literature review as well as the findings of the cross-sectional survey and the in-depth interview. The intervention effects than will be evaluated using outcomes including delirium incidence, delirium duration, delirium severity, ICU patients' consciousness and cognitive function as well as family members' satisfaction and anxiety. This study is expected to provide evidence of the effectiveness of family-supported sensory stimulation on preventing delirium among ICU patients.

Enrollment

152 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years
  • the first time admitted to ICU
  • a Richmond Agitation-Sedation Scale (RASS) score ≥-3

Exclusion criteria

  • diagnosed with stroke, dementia, delirium or acute psychiatric illness at admission
  • diagnosed with end-stage of cancer
  • severe hearing impairment and cannot be corrected by hearing aids
  • admitted to ICU with radiative material.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

152 participants in 2 patient groups

Sensory stimulation
Experimental group
Description:
Participants allocated to the intervention group will receive a model-based sensory stimulation intervention, which is aimed at providing visual and auditory stimulation to ICU patients with additional support from family caregivers.
Treatment:
Other: Sensory stimulation
Usual care
No Intervention group
Description:
Participants in the control group will receive usual care routine that they are receiving or planning to receive. The registered ICU nurses will provide the same nursing care as previously, including but not limiting to the use of sedation, analgesia, spontaneous breathing trial, indwelling catheter, feeding, and bowel care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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