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

NCT ID: NCT04306016

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Sensory stimulation

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.

Group Type: EXPERIMENTAL

Sensory stimulation

Intervention Type: 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.

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sensory stimulation

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Liang Surui

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2019.521

Identifier Type: -

Identifier Source: org_study_id