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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings