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

January 19, 2026 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yun-Hsiang Lee Associate Professor, PhD
  • Phone Number: +886 978082338
  • Email: yhlee338@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Exclusion Criteria:

- Unwilling to participate in the qualitative interview.

Stage 2 (only for patients) ***Intervention group***

Inclusion Criteria:

  • Aged 18 years or older.
  • Diagnosed with gynecologic cancer and scheduled to undergo surgery.
  • Willing to receiveE-MOTE robot and to 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.

***Control group***

Inclusion Criteria:

  • Aged 18 years or older.
  • Diagnosed with gynecologic cancer and scheduled to undergo surgery.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Routine care
Experimental: Intervention Group
The intervention group will receive the E-MOTE robot, which conducts emotional assessments, and provides a session of self-affirmation relaxation training followed by a Q&A session.
Other: E-MOTE group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress
Time Frame: Measurements 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.
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Depression
Time Frame: Measurements 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.
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the robot
Time Frame: Measurements 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.
Measurements will be taken three days post-surgery.
Quality of Life Measurement
Time Frame: Measurements 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.
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Loneliness
Time Frame: Measurements 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.
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Symptom Severity
Time Frame: Measurements 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.
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Physiological objective indicators
Time Frame: Measurements 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.
Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 25, 2025

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202504008RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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