UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059604 |
|---|---|
| Receipt number | R000068189 |
| Scientific Title | An exploratory study on the psychological and physiological effects of medical interviews using interactive robot avatars on patients and physicians |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/10/31 16:04:51 |
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Basic information
Public title
A study exploring how medical interviews using interactive robots or avatars affect patients and physicians
Acronym
Exploratory study on the effects of avatar-mediated medical interviews
Scientific Title
An exploratory study on the psychological and physiological effects of medical interviews using interactive robot avatars on patients and physicians
Scientific Title:Acronym
Exploratory study on the effects of avatar-mediated medical interviews
Region
| Japan |
Condition
Condition
Gynecologic malignancies, benign gynecologic tumors, and gynecologic health care-related conditions such as dysmenorrhea and menopausal disorders
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to clarify the psychological and physiological effects of medical interviews conducted via an interactive robot avatar on both patients and physicians.This exploratory study aims to examine how avatar-mediated interviews, compared with conventional face-to-face physician interviews, influence patients'psychological burden, physicians' stress responses, the quality of communication, and mutual understanding.
Basic objectives2
Others
Basic objectives -Others
To explore the underlying psychological and physiological mechanisms by which interactive robot avatars influence patient-physician communication.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in psychological stress levels of patients and physicians before and after each interview, evaluated by the change in mood and emotional state measured using the Profile of Mood States, Second Edition (POMS2), and compared between the physician-mediated and avatar-mediated interview conditions.
Key secondary outcomes
Patient and physician satisfaction, psychological burden, and level of understanding will be evaluated before and after each interview.
During each interview, physiological parameters such as heart rate variability, voice features, and emotion indicators derived from facial expression analysis will be measured.
Furthermore, plasma metabolites and hormones, as well as multi-omics analyses of peripheral blood mononuclear cells (PBMCs)-including gene expression and metabolic profiles, obtained from blood samples collected before and after each interview will be compared between the physician-mediated and avatar-mediated interview conditions.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Each patient will undergo two interviews one is a standard medical interview conducted by a physician and the other is an interview conducted via an interactive robot avatar. During the avatar-mediated interview the physician will remotely control the avatar either fully or partially. Each interview will last approximately 30 to 60 minutes. The conversation mainly consists of questions about the patients symptoms and physical condition as well as discussions regarding concerns or questions about their disease or treatment. This study adopts a within-subject self-controlled randomized crossover design.The first interview will be conducted by a physician, and the second interview will be conducted via an avatar.
Interventions/Control_2
Each patient will undergo two interviews one is a standard medical interview conducted by a physician and the other is an interview conducted via an interactive robot avatar. During the avatar-mediated interview the physician will remotely control the avatar either fully or partially. Each interview will last approximately 30 to 60 minutes. The conversation mainly consists of questions about the patients symptoms and physical condition as well as discussions regarding concerns or questions about their disease or treatment. This study adopts a within-subject self-controlled randomized crossover design.The first interview will be conducted via an avatar, and the second interview will be conducted by a physician.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Obstetricians and patients receiving gynecologic care who are 18 years of age or older, understand the content of this study, and provide written informed consent.
Key exclusion criteria
Participants who meet any of the following criteria will be excluded:
Individuals who lack sufficient judgment, are unconscious, or whose diagnosis requires special consideration.
Patients with serious complications that are life-threatening.
Individuals who have not provided informed consent or who have withdrawn their consent.
Any other patients whom the principal investigator or co-investigators judge to be inappropriate for participation in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mandai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gynecology and Obstetrics
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
0757513269
rin0617@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Rin |
| Middle name | |
| Last name | Mizuno |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gynecology and Obstetrics
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
0757513269
Homepage URL
rin0617@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Consultation Office, Kyoto University Hospital
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
Tel
0757514748
ctsodan@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068189
