Emotional Assessment and Tiered Individualized Psychological Support of the Artificial Intelligence Robot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
To develop the E-MOTE robot and evaluate its effectiveness in addressing psychological distress, physical symptom, stress index, and quality of life, as well as to explore its clinical applicability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 years or older.
Diagnosed with gynecologic cancer and undergoing surgery.
Willing to receive E-MOTE robot and wear a smart wearable device.
Willing to complete pre-test and post-test questionnaires.
Disqualifiers
Unable to communicate clearly.
Unwilling or unable to participate in the study in its entirety.
Aged 18 years or older.
As a clinical nurse and has cared for patients who received the E-MOTE robot
Trial design
Design model
Parallel
Treatments tested in this trial
E-MOTE group
Other interventionParticipants in the experimental group will receive the E-MOTE robot intervention on the first and second days after surgery. The intervention includes an emotional assessment, followed by appropriate dialogue modules tailored to the level of emotional distress. These are supplemented with emotion-generated empathetic conversations for deeper engagement, a session of self-affirmation relaxation training, and a subsequent Q\&A session.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Distress
Investigators utilized the Distress Thermometer(DT) as the primary outcome measure. The scale uses a 11 Liker scale, where 0 indicates no distress at all and 10 represents the most severe distress.Higher score indicates a more severe distress. When the score is 4 or higher, a Problem List (PL) is used to further identify factors contributing to the emotional distress.
Time frame
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.2
Depression
Investigators utilized the Patient Health Questionnaire (PHQ-9) as the primary outcome measure to assess depression. The scale consists of 9 items, each rated on a 4-point Likert scale (0 = not at all, 3 = nearly every day). The total score ranges from 0 to 27, and depression severity can be categorized as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20 or above).Higher score indicates a more severe depression.
Time frame
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.Secondary outcomes
1
Usability of the robot
Investigators used Bot Usability Scale(BUS) to asses the usability of the robot. The scale consists of 15 items, each rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), higher score indicates greater usability.
Time frame
Measurements will be taken three days post-surgery.2
Quality of Life Measurement
Investigator use the partial itmes of European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) to measure quality of life. These two item is scored on a scale from 1 to 7, with higher scores indicating better quality of life.
Time frame
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.3
Loneliness
Investigators utilized the Caring Loneliness Scale to assess loneliness. The scale consists of 24 items, each rated on a 5-point Likert scale (1 = never, 5 = always), with higher scores indicating greater feelings of loneliness.
Time frame
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.4
Symptom Severity
Investigators utilized the Numerical Rating Scale to assess participants' subjective experiences by measuring the severity of various symptoms over the past week. Each symptom was rated on a scale from 0 to 10 (0 = no symptoms at all, 10 = the worst severity the participant can imagine). Higher score indicate more severity. This items included difficulty urinating, lower limb lymphedema, hot flashes caused by premature menopause, and perineal dryness.
Time frame
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.Sponsors and contacts
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Source ClinicalTrials.gov