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NCT Number: NCT07645950

Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy

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.

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Key information

Conditions

Pediatric Oncology Parent Radiotherapy

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Julien Welmant

Montpellier, Herault, 34298, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    Distress questionnaire (PedsQL 3.0 Cancer Module score, Varni et al.)

  2. Evaluate the immediate intra-individual effect of MIROKI in children on development of attachment and reassurance

    Time frame: Before, during, and after treatment

    Daily distress VAS (Peds-DTRS score, Patel et al., 2011, 2021) and standardized real-time observation using an observational grid.

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

    Time frame: At the end of treatment

    Post-treatment interview (thematic and lexico-metric analysis).

  4. 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

  5. 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,

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore MOUSSION

CONTACT

[email protected]

0467613102 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Acronym: KOKORO01

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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