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NCT Number: NCT07365761

Emotional Assessment and Tiered Individualized Psychological Support of the 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.

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Key information

Conditions

Emotional Assessment Gynecological Cancers Nursing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University

Taipei, Taiwan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yun-Hsiang Lee Associate Professor, PhD

CONTACT

[email protected]

+886 978082338

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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