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Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy

NCT07645950 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2026-06-12

No results posted yet for this study

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

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Julien, Welmant · ICM Co. Ltd.

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645950 on ClinicalTrials.gov