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Recruiting NCT07365761

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

No phase Interventional Emotional Assessment Nursing Gynecological Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: E-MOTE group.
Who it may be relevant to
Registry conditions: Emotional Assessment, Nursing, Gynecological Cancers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Distress [Time frame: 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.]
Secondary outcome measures (5)
  • Usability of the robot [Time frame: 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.]
  • Loneliness [Time frame: 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.]
  • Physiological objective indicators [Time frame: Measurements will be taken before the intervention, three days after surgery, and one week after discharge.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • National Taiwan University — Taipei

Identifiers

NCT: NCT07365761 · 202504008RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗