Clinical trial NCT04306016: The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial
Official title: The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium, Intensive Care Unit, Randomised Controlled Trial
Keywords: Delirium, sensory stimulation, intensive care unit, prevention
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An assessor-blinded two-arm randomised controlled trial (RCT) will be conducted.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Delirium incidence
timeFrame: Through study completion, an average of seven days
measure: First occurrence of delirium
timeFrame: Through study completion, an average of seven days
measure: Delirium duration
timeFrame: Through study completion, an average of seven days
measure: Delirium severity
timeFrame: Through study completion, an average of seven days
Secondary outcomes:
measure: Post-traumatic stress disorder (PTSD)
timeFrame: Through study completion, an average of seven days
measure: Depressive symptoms
timeFrame: Through study completion, an average of seven days
measure: Family satisfaction
timeFrame: Through study completion, an average of seven days
measure: Level of anxiety
timeFrame: Through study completion, an average of seven days
measure: ICU memory
timeFrame: Through study completion, an average of seven days
measure: Depressive symptoms
timeFrame: At one month upon patients' admission to ICU
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: