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Emotional Assessment and Tiered Individualized Psychological Support of the Artificial Intelligence Robot

Emotional Assessment and Tiered Individualized Psychological Support for Newly Diagnosed Postoperative Gynecologic Patients: Development and Testing of the E-MOTE Artificial Intelligence Robot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07365761
Enrollment
130
Registered
2026-01-26
Start date
2025-10-01
Completion date
2026-07-31
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Assessment, Gynecological Cancers, Nursing

Keywords

Artifical inteligence, Robot, Emotional assessment, Psychological support, Nursing

Brief summary

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.

Detailed description

This study is grounded in the Social Cognitive Theory of Self-Regulation as its theoretical framework and aims to develop a robot equipped with functions of Emotion, Monitor, Optimize, Tailor, and Engage (E-MOTE). The intervention is designed to support newly diagnosed gynecological cancer patients in more effectively managing their emotions throughout the surgical treatment process, with the goal of positively influencing symptom management and quality of life.At the same time, the investigators will conduct qualitative interviews with nursing staff to understand their perceptions and thoughts about the robot.

Interventions

Participants 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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

This intervention module will first classify different levels of emotional distress using the Distress Thermometer, then provide corresponding dialogue modules tailored to the severity. These will be accompanied by emotion-generated empathetic conversations for deeper engagement, followed by a guided session of self-affirmation relaxation training. Subsequently, a Q&A session on the self-affirmation relaxation training will be conducted to reinforce the practice.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Stage 1 (For patients and nurse) \*\*\*Patients\*\*\* Inclusion Criteria: * 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.

Exclusion criteria

* Unable to communicate clearly. * Unwilling or unable to participate in the study in its entirety. \*\*\*Nurse\*\*\* Inclusion Criteria: * Aged 18 years or older. * As a clinical nurse and has cared for patients who received the E-MOTE robot

Design outcomes

Primary

MeasureTime frameDescription
DistressMeasurements will be taken before the intervention, three days after surgery, and one week after discharge.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.
DepressionMeasurements will be taken before the intervention, three days after surgery, and one week after discharge.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.

Secondary

MeasureTime frameDescription
Usability of the robotMeasurements will be taken three days post-surgery.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.
Quality of Life MeasurementMeasurements will be taken before the intervention, three days after surgery, and one week after discharge.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.
LonelinessMeasurements will be taken before the intervention, three days after surgery, and one week after discharge.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.
Symptom SeverityMeasurements will be taken before the intervention, three days after surgery, and one week after discharge.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.
Physiological objective indicatorsMeasurements will be taken before the intervention, three days after surgery, and one week after discharge.Objective physiological indicators were measured using wearable smart wristbands, including heart rate, heart rate variability, and stress index.

Countries

Taiwan

Contacts

CONTACTYun-Hsiang Lee Associate Professor, PhD
yhlee338@ntu.edu.tw+886 978082338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026