Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy

NCT07645950 | Not Yet Recruiting

• 1 other identifier: PROICM 2026-01 KOK
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluate the immediate intra-individual effect of MIROKI in children on: Psychological distress level

  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

  Before, during, and after treatment

• Evaluate the satisfaction with care (radiotherapy at ICM) at the end of treatment

  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

  Before the start , during and after the treatment,

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Parent of a child enrolled in the study.
• Able to speak French.
• \. 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Julien Welmant

Montpellier, Herault, 34298, France

Location

Related 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 Officials

• Julien, Welmant

  ICM Co. Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore MOUSSION

CONTACT

0467613102; drci-icm105@icm.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
• 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.

Locations

FR (1)