Delirium, Intensive Care Unit, Randomised Controlled TrialNCT04306016
The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial
A study testing Sensory stimulation in people with Delirium, Intensive Care Unit, Randomised Controlled Trial, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Delirium, Intensive Care Unit, Randomised Controlled Trial
- What is being tested?
- Sensory stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- the first time admitted to ICU
- a Richmond Agitation-Sedation Scale (RASS) score ≥-3
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
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.
- Being tested
- Sensory stimulation
- Keywords
- Delirium, sensory stimulation, intensive care unit, prevention
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium incidence
Delirium incidence means the number of patients who are delirious.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of seven days
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At one month upon patients' admission to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, Intensive Care Unit, Randomised Controlled TrialStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An assessor-blinded two-arm randomised controlled trial (RCT) will be conducted.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Surui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306016
- Sponsor's protocol ID
- 2019.521
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Model-based Sensory Stimulation Intervention on Preventing Delirium Among Intensive Care Unit Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04306016
- Acronym / sponsor ID
- 2019.521
- Keywords
- Delirium, sensory stimulation, intensive care unit, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An assessor-blinded two-arm randomised controlled trial (RCT) will be conducted.
| Arm | Type | Receives |
|---|---|---|
| Sensory stimulation | Experimental | Other: Sensory stimulationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years
- the first time admitted to ICU
- a Richmond Agitation-Sedation Scale (RASS) score ≥-3
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory stimulationSensory 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. | Other | Sensory stimulation |
Primary outcome
Delirium incidence
Time frame: Through study completion, an average of seven days
Delirium incidence means the number of patients who are delirious.
First occurrence of delirium
Time frame: Through study completion, an average of seven days
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.
Delirium duration
Time frame: Through study completion, an average of seven days
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.
Delirium severity
Time frame: Through study completion, an average of seven days
CAM-ICU-7 scores are further categorised as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
6 secondary outcomes
Post-traumatic stress disorder (PTSD)
Time frame: Through study completion, an average of seven days
Depressive symptoms
Time frame: Through study completion, an average of seven days
Family satisfaction
Time frame: Through study completion, an average of seven days
Level of anxiety
Time frame: Through study completion, an average of seven days
ICU memory
Time frame: Through study completion, an average of seven days
Depressive symptoms
Time frame: At one month upon patients' admission to ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory stimulation in people with Delirium, Intensive Care Unit, Randomised Controlled Trial, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium incidence (time frame: Through study completion, an average of seven days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.