Eye-Tracking Communication Tool for Non-verbal ICU Patients

N/ANot Yet RecruitingNCT07205419

Shanghai Zhongshan Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Communication Barriers Eye-tracking Technology ICU Patients

Interventions

Outcomes

Primary Outcomes

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 enrollment

Secondary Outcomes

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 daily

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 enrollment

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 enrollment

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 year

Time spent training patients during initial use

The research team is going to independently develop a Communication Information Registration Form, which is to include the duration of training provided by nurses to patients when they use the eye-tracking interactive system for the first time. After the completion of the intervention, the average training duration is to be calculated.

Time frame: Day 1

Patient enrollment rate

The patient enrollment rate is calculated as the number of patients who successfully meet the eligibility criteria and are enrolled in the study divided by the total number of patients screened for eligibility during the study period.

Time frame: through study completion, an average of 2 year

Patient withdrawal rate

The patient withdrawal rate is defined as the number of enrolled patients who discontinue study participation (for any reason) prior to the completion of the predefined study protocol (e.g., intervention course) divided by the total number of enrolled patients.