Emotional AssessmentNCT07365761
Emotional Assessment and Tiered Individualized Psychological Support of the Artificial Intelligence Robot
A study testing E-MOTE group in people with Emotional Assessment and Nursing, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Assessment, Nursing, Gynecological Cancers
- What is being tested?
- E-MOTE group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2025to 31 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Aged 18 years or older.
- As a clinical nurse and has cared for patients who received the E-MOTE robot
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- 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.
- Aged 18 years or older.
- Diagnosed with gynecologic cancer and scheduled to undergo surgery.
- Willing to complete pre-test and post-test questionnaires.
Who cannot join
- Unable to communicate clearly.
- Unwilling or unable to participate in the study in its entirety.
- Nurse
- Unwilling to participate in the qualitative interview.
- Stage 2 (only for patients) Intervention group
- Unable to communicate clearly.
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- Unwilling or unable to participate in the study in its entirety.
- Control group
- Unable to communicate clearly.
- Unwilling or unable to participate in the study in its entirety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Emotional Assessment, Nursing, Gynecological Cancers
- Being tested
- E-MOTE group
- Keywords
- Artifical inteligence, Robot, Emotional assessment, Psychological support, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-MOTE groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: E-MOTE group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Secondary outcomes (5)
Usability of the robot
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.
Measured: Measurements will be taken three days post-surgery.
Quality of Life Measurement
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.
Measured: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Loneliness
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.
Measured: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Symptom Severity
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.
Measured: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Physiological objective indicators
Objective physiological indicators were measured using wearable smart wristbands, including heart rate, heart rate variability, and stress index.
Measured: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional AssessmentStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365761
- Sponsor's protocol ID
- 202504008RINC
- Status last verified
- Oct 2025
- First submitted
- 25 Jul 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided