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

NCT07365761 | Recruiting

• 1 other identifier: 202504008RINC
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Assessment; Nursing; Gynecological Cancers

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

• 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.

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

Secondary Outcomes (5)

• Usability of the robot

  Measurements will be taken three days post-surgery.

• Quality of Life Measurement

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

• Loneliness

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

• Symptom Severity

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

• Physiological objective indicators

  Measurements will be taken before the intervention, three days after surgery, and one week after discharge.

Study Arms (2)

Control Group

NO INTERVENTION

Routine care

Intervention Group

EXPERIMENTAL

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

Interventions

E-MOTE group OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to communicate clearly.
• Unwilling or unable to participate in the study in its entirety.
• \*\*\*Nurse\*\*\*
• Aged 18 years or older.
• As a clinical nurse and has cared for patients who received the E-MOTE robot
• \- Unwilling to participate in the qualitative interview.
• Stage 2 (only for patients) \*\*\*Intervention group\*\*\*
• 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.
• Unable to communicate clearly.
• Unwilling or unable to participate in the study in its entirety.
• \*\*\*Control group\*\*\*
• Aged 18 years or older.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, Taiwan

RECRUITING

Central Study Contacts

Yun-Hsiang Lee Associate Professor, PhD

CONTACT

+886 978082338; yhlee338@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: January 26, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-10

Locations

TW (1)