Eye-Tracking Communication Tool for Non-verbal ICU Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
The objectives of this clinical trial are to explore the feasibility of the eye-tracking communication tool in alleviating communication barriers among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this tool in facilitating communication for these patients.
Researchers will compare the eye-tracking communication tool with conventional techniques (such as body language, writing boards, etc.) to observe the feasibility and preliminary effectiveness of the eye-tracking communication tool in alleviating communication barriers.
Participants will use an eye-tracking communication tool for augmentative communication for 2 consecutive days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged ≥ 18 years
unable to communicate through normal verbal means due to endotracheal intubation/tracheotomy, muscle or nerve injury, acute/chronic spinal cord injury, etc.
Richmond Agitation-Sedation Scale (RASS) score ranging from -1 to 1
able to comply with simple instructions for study participation
Disqualifiers
blindness or inability to elevate the eyelids that preclude successful participation in eye-tracking interaction tasks
cognitive impairment limiting meaningful participation
severe psychological distress
aged ≥ 18 years
Trial design
Design model
Parallel
Treatments tested in this trial
Eye-Tracking communication tool
DeviceAn eye-tracking communication tool developed using a human-centered co-design approach.The eye-tracking communication tool consists of an eye-tracker, a tablet, and a floor-standing stand. The tool will be placed at the patient's bedside 24 hours a day to facilitate real-time communication.
Conventional Techniques
Other interventionbody language (e.g., pointing, nodding, shaking the head) and writing boards
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Control Group:conventional techniques groupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Communication difficulty
The degree of communication difficulty in non-verbal ICU patients will be assessed using the Ease of Communication Scale. This tool was revised by Menzel et al.in 1998 and has previously been used to assess communication difficulties among non-verbal patients in the ICU. The scale comprises 6 items, with response options ranging from 0 (no difficulty at all) to 4 (extreme difficulty). The total score ranges from 0 to 24, with higher scores indicating greater communication difficulties.
Time frame
up to 2days after enrollmentSecondary outcomes
1
Well-being and safety
The degree of well-being and safety in non-verbal ICU patients will be assessed using the practical co-constructed intensive care patients' well-being and safety scale (TOURS Scale). This scale consists of 4 items, with response options ranging from 0 (not at all) to 3 (very). The total score ranges from 0 to 12, with higher scores indicating better well-being and safety.
Time frame
at 4:00 PM daily2
Satisfaction of family members
Family satisfaction will be assessed using the FS-ICU-24 scale. This scale consists of 24 items and has been well validated for measuring satisfaction among family members of patients admitted to the ICU. The scale comprises two domains: satisfaction with care and satisfaction with decision-making. Each item is scored on a continuous scale ranging from 0 to 100. The domain score is calculated as the sum of all valid item scores within that domain divided by the number of valid items in the respective domain. The total FS-ICU-24 score is computed as the sum of the two domain mean scores divided by 2, with higher scores representing a higher level of satisfaction.
Time frame
up to 2 days after enrollment3
Communication burden of ICU healthcare professionals
The communication burden of ICU healthcare professionals will be assessed using the NASA-TLX. This scale has been widely used to evaluate the subjective workload of healthcare providers and covers six domains: mental demand, physical demand, temporal demand, performance level, effort, and frustration. Each of the six domains is scored on a continuous scale ranging from 0 to 100, where a score of 0 indicates the lowest level of the domain and a score of 100 indicates the highest level.
Time frame
up to 2 days after enrollment4
Nurses' compliance
Nurses' intervention behaviors will be documented during unscheduled supervision.The compliance of nurses will be defined as the number of communication sessions conducted by nurses with intervention group patients via the communication tool divided by the total number of communication sessions.
Time frame
through study completion，an average of 2 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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