Pediatric OncologyKOKORO01NCT07645950
Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy
An observational study of Pediatric Oncology and Radiotherapy, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Pediatric radiotherapy is an anxiety-provoking situation that can, on one hand, impair the child's cooperation and require sedation, and on the other hand,burden the care pathway by generating significant anxiety in both the child and their parents. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Oncology, Radiotherapy, Parent
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be recruited from the pediatric radiotherapy unit at Montpellier Cancer Institute (ICM).During the initial consultation to initiate radiotherapy treatment at ICM, the investigator physician will present the KOKORO-01 study. They will answer all questions regarding its procedures and will provide the parents or legal representative with the information sheet and consent form. Parents or the legal representative will have at least one week to consider participation, during which they may ask any questions they wish.
Who may be able to join
- Children aged 4 to 18 years, distributed across the following age groups: 4-7 years, 8-12 years, and 13-18 years.
- Child with an indication for radiotherapy treatment at ICM.
- Child who speaks French.
- Child accompanied by a parent or legal guardian who agrees to participate in the study and provide consent.
- Child covered by the French national health insurance system.
Who cannot join
- 6. Child with a diagnosed neurodevelopmental disorder as a comorbidity. 7. Child with postoperative cognitive sequelae that make interaction during care difficult (e.g., language impairment). 8. Total body irradiation. 9. Child under legal protection, unable to express assent, or presenting major difficulties in understanding the study information. Parent Inclusion Criteria
- Parent of a child enrolled in the study.
- Able to speak French.
- Willing to participate in the study. Parent Exclusion Criteria
- 1. Parents or legal representatives under legal protection, or presenting an inability to consent or to understand the study information, making it impossible to provide free and informed consent for the minor's participation.
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
Pediatric radiotherapy is an anxiety-provoking situation that can, on one hand, impair the child's cooperation and require sedation, and on the other hand,burden the care pathway by generating significant anxiety in both the child and their parents. Companion robots represent an innovative avenue for patient support, but they have never been evaluated in the context of radiotherapy. This study examines the effect of MIROKI, the first social robot capable of communication through a Large Multimodal Model (LMM), on children's state anxiety during radiotherapy. An experimental single-case design (SCED) will compare phases with and without the robot (withdrawal/reversal), both in the waiting room and in the irradiation bunker. The primary outcome variable is anxiety, assessed in several ways: through questionnaires at the beginning and end of treatment; through an objective measure of cardiac activity (heart rate in bpm) during the radiotherapy session, with or without the MIROKI robot; and through an observational grid assessing the child's behavior. The intensive repeated measure (bpm) constitutes the preferred variable in this SCED design, while behavioral observation and anxiety questionnaires will support interpretation. The results could pave the way for reducing sedation and improving the overall care pathway in pediatric radiotherapy.
- Conditions
- Pediatric Oncology, Radiotherapy, Parent
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the immediate intra-individual effect of MIROKI on a physiological marker of anxiety in children undergoing radiotherapy.
The child's anxiety level measured through an objective assessment of heart rate (bpm sensor).
Measured: During the treatment, across the 6 radiotherapy sessions
Secondary outcomes (5)
Evaluate the immediate intra-individual effect of MIROKI in children on: Psychological distress level
Distress questionnaire (PedsQL 3.0 Cancer Module score, Varni et al.)
Measured: administered before the start of treatment and after completion of treatment
Evaluate the immediate intra-individual effect of MIROKI in children on development of attachment and reassurance
Daily distress VAS (Peds-DTRS score, Patel et al., 2011, 2021) and standardized real-time observation using an observational grid.
Measured: Before, during, and after treatment
Evaluate the satisfaction with care (radiotherapy at ICM) at the end of treatment
Post-treatment interview (thematic and lexico-metric analysis).
Measured: At the end of treatment
Evaluate the impact of MIROKI on the radiotherapy process: Setup time during sessions in the radiotherapy room
Measured: From the beginning to the end of the treatment course
Evaluate the impact of MIROKI on parents: - Anxiety level - Satisfaction with care at the end of treatment - Experience of the radiotherapy process at the end of treatment
- Anxiety score (GAD-7, Spitzer et al., 2006)
- Parent-child relationship quality score (CPRS, Pianta et al., 1992)
During treatment:
- Daily anxiety VAS (daily DT score, Leclair et al., 2016; NCCN, 2025)
After treatment:
- Assessment of the radiotherapy experience and satisfaction with care with the robot, using the parent interview grid
Measured: Before the start , during and after the treatment,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric OncologyStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien, Welmant, Principal investigator, ICM Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645950
- Sponsor's protocol ID
- PROICM 2026-01 KOK
- Acronym
- KOKORO01
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy
- ClinicalTrials.gov ID
- NCT07645950
- Acronym / sponsor ID
- KOKORO01 / PROICM 2026-01 KOK
- Conditions
- Pediatric Oncology, Radiotherapy, Parent
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric radiotherapy is an anxiety-provoking situation that can, on one hand, impair the child's cooperation and require sedation, and on the other hand,burden the care pathway by generating significant anxiety in both the child and their parents. Companion robots represent an innovative avenue for patient support, but they have never been evaluated in the context of radiotherapy. This study examines the effect of MIROKI, the first social robot capable of communication through a Large Multimodal Model (LMM), on children's state anxiety during radiotherapy. An experimental single-case design (SCED) will compare phases with and without the robot (withdrawal/reversal), both in the waiting room and in the irradiation bunker. The primary outcome variable is anxiety, assessed in several ways: through questionnaires at the beginning and end of treatment; through an objective measure of cardiac activity (heart rate in bpm) during the radiotherapy session, with or without the MIROKI robot; and through an observational grid assessing the child's behavior. The intensive repeated measure (bpm) constitutes the preferred variable in this SCED design, while behavioral observation and anxiety questionnaires will support interpretation. The results could pave the way for reducing sedation and improving the overall care pathway in pediatric radiotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited from the pediatric radiotherapy unit at Montpellier Cancer Institute (ICM).During the initial consultation to initiate radiotherapy treatment at ICM, the investigator physician will present the KOKORO-01 study. They will answer all questions regarding its procedures and will provide the parents or legal representative with the information sheet and consent form. Parents or the legal representative will have at least one week to consider participation, during which they may ask any questions they wish.
Key inclusion criteria (5 listed)
- Children aged 4 to 18 years, distributed across the following age groups: 4-7 years, 8-12 years, and 13-18 years.
- Child with an indication for radiotherapy treatment at ICM.
- Child who speaks French.
- Child accompanied by a parent or legal guardian who agrees to participate in the study and provide consent.
- Child covered by the French national health insurance system.
Key exclusion criteria (5 listed)
- 6. Child with a diagnosed neurodevelopmental disorder as a comorbidity. 7. Child with postoperative cognitive sequelae that make interaction during care difficult (e.g., language impairment). 8. Total body irradiation. 9. Child under legal protection, unable to express assent, or presenting major difficulties in understanding the study information. Parent Inclusion Criteria
- Parent of a child enrolled in the study.
- Able to speak French.
- Willing to participate in the study. Parent Exclusion Criteria
- 1. Parents or legal representatives under legal protection, or presenting an inability to consent or to understand the study information, making it impossible to provide free and informed consent for the minor's participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the immediate intra-individual effect of MIROKI on a physiological marker of anxiety in children undergoing radiotherapy.
Time frame: During the treatment, across the 6 radiotherapy sessions
The child's anxiety level measured through an objective assessment of heart rate (bpm sensor).
5 secondary outcomes
Evaluate the immediate intra-individual effect of MIROKI in children on: Psychological distress level
Time frame: administered before the start of treatment and after completion of treatment
Evaluate the immediate intra-individual effect of MIROKI in children on development of attachment and reassurance
Time frame: Before, during, and after treatment
Evaluate the satisfaction with care (radiotherapy at ICM) at the end of treatment
Time frame: At the end of treatment
Evaluate the impact of MIROKI on the radiotherapy process: Setup time during sessions in the radiotherapy room
Time frame: From the beginning to the end of the treatment course
Evaluate the impact of MIROKI on parents: - Anxiety level - Satisfaction with care at the end of treatment - Experience of the radiotherapy process at the end of treatment
Time frame: Before the start , during and after the treatment,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Bamberger, K. T. (2016). The Application of Intensive Longitudinal Methods to Investigate Change: Stimulating the Field of Applied Family Research. Clinical Child and Family Psychology 1040 ReviewLink provided by the sponsor.
- Dominique Interactif pour Adolescents-Révisé, dépression, comorbidité et suicidalitéLink provided by the sponsor.
- Interpreting Kendall's Tau and Tau-U for single-case experimental designsLink provided by the sponsor.
- Prediction of compliance with MRI procedures among children of ages 3 years to 12 yearsLink provided by the sponsor.
- Examining the perceived social support and psychological symptoms among adolescents with leukemiaLink provided by the sponsor.
- Pediatric radiotherapy preparation: a scoping reviewLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julien, Welmant principal investigator
ICM Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Oncology and Radiotherapy, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore MOUSSION (0467613102 ext. +33, drci-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the immediate intra-individual effect of MIROKI on a physiological marker of anxiety in children undergoing radiotherapy. (time frame: During the treatment, across the 6 radiotherapy sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.