Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy (KOKORO01)

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 Overview

• Status: Not yet recruiting
• Conditions: Radiotherapy; Pediatric Oncology; Parent

• Study Type: Observational
• Enrollment (Estimated): 6

Contacts and Locations

• Study Contact: Name: Aurore MOUSSION; Phone Number: +33 0467613102; Email: drci-icm105@icm.unicancer.fr

Study Locations

• France
  • Herault
    • Montpellier, Herault, France, 34298
      • Julien Welmant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

1. Children aged 4 to 18 years, distributed across the following age groups: 4-7 years, 8-12 years, and 13-18 years.
2. Child with an indication for radiotherapy treatment at ICM.
3. Child who speaks French.
4. Child accompanied by a parent or legal guardian who agrees to participate in the study and provide consent.
5. Child covered by the French national health insurance system.

Exclusion Criteria:

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

1. Parent of a child enrolled in the study.
2. Able to speak French.
3. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During the treatment, across the 6 radiotherapy sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	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.	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).	At the end of treatment
Evaluate the impact of MIROKI on the radiotherapy process: Setup time during sessions in the radiotherapy room		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	Before the start , during and after the treatment,

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Principal Investigator: Julien, Welmant, ICM Co. Ltd.

Publications and helpful links

Helpful Links

• 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 Review
• Dominique Interactif pour Adolescents-Révisé, dépression, comorbidité et suicidalité
• Prediction of compliance with MRI procedures among children of ages 3 years to 12 years
• Examining the perceived social support and psychological symptoms among adolescents with leukemia
• Pediatric radiotherapy preparation: a scoping review
• Consultation with children in hospital: children, parents' and nurses' perspectives
• The Family of Single-Case Experimental Designs
• Children's experiences and responses towards an intervention for psychological preparation for radiotherapy

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PROICM 2026-01 KOK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
• IPD Sharing Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No