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

NCT04306016 | Completed

• 1 other identifier: 2019.521
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium, Intensive Care Unit, Randomised Controlled Trial

Keywords

Delirium, sensory stimulation, intensive care unit, prevention

Outcome Measures

Primary Outcomes (4)

• Delirium incidence

  Delirium incidence means the number of patients who are delirious.

  Through study completion, an average of seven days

• First occurrence of delirium

  First occurrence of delirium was defined as the first time that patients was delirium positive through CAM-ICU. The time to have the first occurrence of delirium was calculated from patients' admission to ICU to the first positive result of delirium assessment.

  Through study completion, an average of seven days

• Delirium duration

  The delirium duration will be calculated when the patient is first considered to have delirium to the last time that patient is not supposed to have delirium based on CAM-ICU.

  Through study completion, an average of seven days

• Delirium severity

  CAM-ICU-7 scores are further categorised as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.

  Through study completion, an average of seven days

Secondary Outcomes (6)

• Post-traumatic stress disorder (PTSD)

  Through study completion, an average of seven days

• Depressive symptoms

  Through study completion, an average of seven days

• Family satisfaction

  Through study completion, an average of seven days

• Level of anxiety

  Through study completion, an average of seven days

• ICU memory

  Through study completion, an average of seven days

Study Arms (2)

Sensory stimulation

EXPERIMENTAL

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.

Other: Sensory stimulation

Usual care

NO INTERVENTION

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.

Interventions

Sensory stimulation OTHER

Sensory stimulation can be formed in different aspects, and the most important ones are visual stimulation and auditory stimulation. Visual stimulation interventions involved providing a calendar, clock or familiar objects such as photographs of family caregivers; while auditory stimulation included calling the name of patients, helping to orientate the time and location, introducing hospital information, the ICU surrounding and treatment, and communicating with patients, who could not talk due to artificial airway, through a blackboard and use of gestures.

Sensory stimulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be blinded to the group allocation and will not be involved in data analysis and results reporting.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: An assessor-blinded two-arm randomised controlled trial (RCT) will be conducted.

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 12, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

CN (1)