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

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.

Study Overview

• Status: Completed
• Conditions: Delirium, Intensive Care Unit, Randomised Controlled Trial
• Intervention / Treatment: Other: Sensory stimulation

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-traumatic stress disorder (PTSD)	The 17-item PTSD Checklist (PCL) correspond to the DSM-III-R symptoms of PTSD (post-traumatic stress disorder), which is a self-reporting scale for assessing PTSD (Frank et al., 1993; Mollica et al., 1992). Patients were asked for their agreement to describe each item, from one (not at all) to five (extremely). PTSD-symptoms could be divided into re-experiencing (flashback, nightmare, emotional cue reactivity, and physical cue reactivity), avoidance and emotional numbing (avoidance of thoughts and reminders, amnesia, loss of interest, detachment, restricted affect, and foreshortened future) and hyperarousal (irritability/anger, sleep disturbance, difficulty concentrating, hypervigilance, exaggerated startle response). The total score was summed and ranged from 17 to 85	Through study completion, an average of seven days
Depressive symptoms	The 9-item Chinese version of Patient Health Questionnaire-9 (PHQ-9) will be used to measure patients' psychological well-being.Patients will be asked for their agreement to the description of each item, from zero (not at all) to three (nearly every day). All item scores are summed (total score = 27). A higher score indicates greater severity of the depressive symptoms.	Through study completion, an average of seven days
Family satisfaction	Family satisfaction will be measured using the Critical Care Family Satisfaction Survey (CCFSS).CCFSS has 27 items and five dimensions: medical condition guarantee, access to information, acceptance, support, and comfort. Family caregivers will be asked for their agreement to the description of each item, from one (very unsatisfactory) to five (very satisfactory). All item scores are summed (total score = 135). A higher score indicates a greater level of satisfaction.	Through study completion, an average of seven days
Level of anxiety	The level of anxiety of family caregivers will be measured by the Self-Rating Anxiety Scale (SAS). SAS has 20 items, with each item ranging from one (not at all) to four (very much so). The scale will use both positive and negative scoring, with a total score of 50-59 indicating mild anxiety, 60-69 indicating moderate anxiety, and ≥70 indicating severe anxiety.	Through study completion, an average of seven days
ICU memory	The ICU-Memory Tool (ICU-M) was used to measure ICU patients' ICU experience (Jones et al., 2000). The tool includes 14 questions (five open-ended questions and nine closed-ended questions), mainly including three parts: memories before admission to ICU; memories during ICU stay and memories after transferring out of ICU. Memories during ICU stay has three subscales: factual memories (lights, alarms, voices, families, faces, breathing tube, suctioning, darkness, clock, tube in your mouth, and ward wounds), memories of feelings (being uncomfortable, confused, down, anxious/ frightened, panic, and pain), and memories of delusions (feeling that people were trying to hurt you, hallucinations, nightmares, dreams). We summed the number of memories in each of the three subscales. The Chinese version of ICU-M has a Cronbach α coefficient of 0.823 and a scale-level content validity index of 0.946, which confirms its good reliability and validity	Through study completion, an average of seven days
Depressive symptoms	The 9-item Chinese version of Patient Health Questionnaire-9 (PHQ-9) will be used to measure patients' psychological well-being.Patients will be asked for their agreement to the description of each item, from zero (not at all) to three (nearly every day). All item scores are summed (total score = 27). A higher score indicates greater severity of the depressive symptoms.	At one month upon patients' admission to ICU

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Delirium, sensory stimulation, intensive care unit, prevention
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2019.521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No